Health and Me

Ishita Roy

Wegovy Approved For MASH Treatment With Fibrosis But No Cirrhosis

<span>Wegovy</span> has been approved by the US Food and Drug Administration (FDA) for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advance fibrosis but without cirrhosis. 

What it means is that FDA has granted approval to <span>Novo Nordisk</span>'s once-weekly 2.4 mg semaglutide subcutaneous injection for treating a liver cell damage, formerly known as NAFLD or nonalcoholic fatty liver disease. This is a condition where excess fat builds up in the liver, unrelated to heavy alcohol use. It is characterized by fat accumulation in the liver, inflammation, and liver cell damage that could potentially lead to fibrosis and cirrhosis. It is also closely linked to metabolic disorders like obesity and type 2 diabetes, which can be treated by Wegovy. Furthermore, the condition is also closely associated with high cholesterol.

<strong>ALSO READ: <a href="https://www.healthandme.com/health-wellness/how-to-identify-a-counterfeit-ozempic-look-for-these-signs-details-inside-article-152480612" data-type="tilCustomLink">How To Identify A Counterfeit Ozempic? Look For These Signs</a></strong> 

The accelerated approval was given on the basis of part-one results from an ongoing two-part, phase 3 ESSENCE trial. This is where Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis. It also showed a resolution of steatohepatitis with no worsening of liber fibrosis as compared with placebo at week 72. The results were also published in April in The New England Journal of Medicine.

The trial involved a total of 800 participants, who were assigned to either Wogovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 54. Most patients were white, which comprised of the 67.5% of the participants, 57.1% of them were women and 55.9% of them were the patients with type 2 diabetes, while 31.3% of them (around 250 patients) had stage II fibrosis and 68.8% (550 patients) had stage II fibrosis. 

It was noted that the patients were on stable doses of lipid-lowering , glucose-management, and <span>weight loss</span> medications. 

At week 72, the trial’s first primary endpoint revealed that 63% of the 534 participants receiving Wegovy achieved resolution of steatohepatitis without worsening liver fibrosis, compared to 34% of the 266 participants on placebo, a statistically significant outcome.

For the second primary endpoint, 37% of those treated with Wegovy showed improvement in liver fibrosis without worsening steatohepatitis, versus 22% in the placebo group, again demonstrating a significant difference.

<strong>READ MORE: <a href="https://www.healthandme.com/health-wellness/weight-loss-drugs-like-ozempic-mounjaro-and-wegovy-under-scrutiny-after-deaths-and-pancreatitis-reports-in-uk-article-152198203" data-type="tilCustomLink">Weight Loss Drugs Like Ozempic, Mounjaro And Wegovy Under Scrutiny After Deaths And Pancreatitis Reports in UK</a></strong>

Novo Nordisk has moved forward with key regulatory submissions for its obesity treatments in 2025. The company filed for approval of its therapies in the European Union in February, followed by a regulatory submission in Japan in May. That same month, the U.S. Food and Drug Administration (FDA) accepted a filing for oral semaglutide 25 mg.

Looking ahead, part 2 of the ESSENCE trial is expected to report results in 2029. The study is designed to evaluate whether Wegovy can reduce the risk of liver-related clinical events in patients with metabolic dysfunction–associated steatohepatitis (MASH) and F2 or F3 fibrosis, compared with placebo, over 240 weeks.

While Novo Nordisk has the technology to manufacture semaglutide in pill form, the company emphasized that the U.S. launch of oral semaglutide for obesity will depend on portfolio priorities and manufacturing capacity. The higher-dose 50 mg oral version has not yet been submitted to regulators.

“The oral form requires more active pharmaceutical ingredient (API),” a spokesperson told Medscape Medical News. “With a fixed amount of API, the injectable form allows us to treat more patients. We are expanding oral and injectable production capacities worldwide, but it takes time to build, validate, and scale these processes.”

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Wegovy has been approved by the US Food and Drug Administration (FDA) for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advance fibrosis but without cirrhosis. What it means is that FDA has granted approval to Novo Nordisk's once-weekly 2.4 mg semaglutide subcutaneous injection for treating a liver cell damage, formerly known as NAFLD or nonalcoholic fatty liver disease. This is a condition where excess fat builds up in the liver, unrelated to heavy alcohol use. It is characterized by fat accumulation in the liver, inflammation, and liver cell damage that could potentially lead to fibrosis and cirrhosis. It is also closely linked to metabolic disorders like obesity and type 2 diabetes, which can be treated by Wegovy. Furthermore, the condition is also closely associated with high cholesterol.ALSO READ: How To Identify A Counterfeit Ozempic? Look For These Signs How Was The Approval Given?The accelerated approval was given on the basis of part-one results from an ongoing two-part, phase 3 ESSENCE trial. This is where Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis. It also showed a resolution of steatohepatitis with no worsening of liber fibrosis as compared with placebo at week 72. The results were also published in April in The New England Journal of Medicine.How Was The Trial Conducted?The trial involved a total of 800 participants, who were assigned to either Wogovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 54. Most patients were white, which comprised of the 67.5% of the participants, 57.1% of them were women and 55.9% of them were the patients with type 2 diabetes, while 31.3% of them (around 250 patients) had stage II fibrosis and 68.8% (550 patients) had stage II fibrosis. It was noted that the patients were on stable doses of lipid-lowering , glucose-management, and weight loss medications. At week 72, the trial’s first primary endpoint revealed that 63% of the 534 participants receiving Wegovy achieved resolution of steatohepatitis without worsening liver fibrosis, compared to 34% of the 266 participants on placebo, a statistically significant outcome.For the second primary endpoint, 37% of those treated with Wegovy showed improvement in liver fibrosis without worsening steatohepatitis, versus 22% in the placebo group, again demonstrating a significant difference.READ MORE: Weight Loss Drugs Like Ozempic, Mounjaro And Wegovy Under Scrutiny After Deaths And Pancreatitis Reports in UKWhat Lies Ahead For Wegovy?Novo Nordisk has moved forward with key regulatory submissions for its obesity treatments in 2025. The company filed for approval of its therapies in the European Union in February, followed by a regulatory submission in Japan in May. That same month, the U.S. Food and Drug Administration (FDA) accepted a filing for oral semaglutide 25 mg.Looking ahead, part 2 of the ESSENCE trial is expected to report results in 2029. The study is designed to evaluate whether Wegovy can reduce the risk of liver-related clinical events in patients with metabolic dysfunction–associated steatohepatitis (MASH) and F2 or F3 fibrosis, compared with placebo, over 240 weeks.While Novo Nordisk has the technology to manufacture semaglutide in pill form, the company emphasized that the U.S. launch of oral semaglutide for obesity will depend on portfolio priorities and manufacturing capacity. The higher-dose 50 mg oral version has not yet been submitted to regulators.“The oral form requires more active pharmaceutical ingredient (API),” a spokesperson told Medscape Medical News. “With a fixed amount of API, the injectable form allows us to treat more patients. We are expanding oral and injectable production capacities worldwide, but it takes time to build, validate, and scale these processes.”

wegovy approved for mash treatment with fibrosis but no cirrhosis

Health & Wellness

‘Ozempic Vulva’: The Bizarre Side Effect Affecting Women’s Health

‘ozempic vulva’: the bizarre side effect affecting women’s health

How To Identify A Counterfeit Ozempic? Look For These Signs, Details Inside

how to identify a counterfeit ozempic? look for these signs, details inside

Iowa-based Pharmacy Faces Charges For Selling Counterfeit Ozempic

ozempic lawsuit iowa-based pharmacy faces charges for selling counterfeit ozempic a popular weight loss and diabetes drug

<strong><span rel="noindex">Ozempic Lawsuit</span>:</strong> "This week's study doesn't suggest that GLP-1 cause your eyes to fall out exactly, but, as you will see in a second, it is not that far off," says Dr F Perry Wilson, MD, MSCE, physician, researcher, educator, and writer, at Yale School of Medicine, before he begins to explain what the new study suggests of the side effects. 

Weight loss drugs have gained popularity up recently. The popularity is for all the right, and the wrong reasons too. While up recently, we have <a href="https://www.healthandme.com/health-news/wegovy-approved-for-mash-treatment-with-fibrosis-but-no-cirrhosis-article-152485354" data-type="tilCustomLink">Wegovy </a>being approved for treating MASH, we also have unheard <a href="https://www.healthandme.com/health-wellness/ozempic-vulva-the-bizarre-side-effect-affecting-womens-health-article-152479988" data-type="tilCustomLink">side effects</a> of the popular drug Ozempic, and not to mention, the cases of <a href="https://www.healthandme.com/health-wellness/weight-loss-drugs-like-ozempic-mounjaro-and-wegovy-under-scrutiny-after-deaths-and-pancreatitis-reports-in-uk-article-152198203" data-type="tilCustomLink">pancreatitis </a>reported in the UK, and the ongoing <a href="https://www.healthandme.com/health-news/ozempic-lawsuit-iowa-based-pharmacy-faces-charges-for-selling-counterfeit-ozempic-a-popular-weight-loss-and-diabetes-drug-article-152480142" data-type="tilCustomLink">lawsuit on Ozempic</a>.

So, what does this new study add to all this?

<h2>Weight Loss Medication And Vision Loss</h2>

Two studies, published in <em>JAMA</em>, analyzed how semaglutide, an injection used to treat type 2 diabetes that helps control your blood sugar, and tirzepatide, an antidiabeteic medication, also used to treat type 2 diabetes and for weight loss, administering via injections, which include popular drugs like Ozempic, Wegovy, Mounjaro and Zepbound, impacted eye health in Americans with type 2 diabetes over a 2-year period.

One of the studies found a modest risk of developing a non-arteritis anterior ischaemic optic neuropathy (NAOIN), which is a rare eye condition that can lead to sudden vision loss due to lack of blood flow. This condition has close links with the consumption of semaglutide and tirzepatide.

Out of more than 159,000 participants with type 2 diabetes, 35 developed NAION, compared to 19 people in the comparison group. The Ohio-based researchers also noted an increased risk of developing "other optic nerve disorders" identified in 93 patients. 

The second study found no statistically significant link between GLP-1 drug use and NAION, a rare eye condition, but reported a slight uptick in cases of diabetic retinopathy, a retinal disease that can cause vision loss.

The study observed that individuals with type 2 diabetes who were treated with GLP-1 drugs faced a modestly higher risk of developing diabetic retinopathy. However, researchers emphasized that fewer patients progressed to sight-threatening stages of the disease. They concluded that all patients with type 2 diabetes receiving GLP-1 therapies should undergo regular screening and monitoring for potential eye complications, regardless of whether they already have diabetic retinopathy.

"These findings suggest that all patients with type 2 diabetes treated with GLP-1 RAs, regardless of preexisting diabetic retinopathy, should be regularly screened and monitored for potential complications," the study authors concluded.

As questions continue to mount about the potential connection between GLP-1 weight-loss drugs and vision problems, experts stress that more research is needed before drawing firm conclusions.

Sue Decotiis, M.D., a medical weight-loss doctor in New York City, said she believes additional studies are required to confirm whether the drugs increase the risk of vision loss, pointing to conflicting findings so far.

"NAION is a rare condition of the optic nerve that, although serious, has not really been shown to be increased by these studies," Decotiis, who was not involved in the research, told<em> Fox News Digital</em>. "We need more studies for certain."

She noted that diabetic patients already face a heightened risk of eye disease due to blood flow and nerve damage. "Eye complications are often directly related to the degree or lack thereof of diabetes control," she explained.

According to Decotiis, GLP-1 drugs often help reduce the severity of type 2 diabetes, which can in turn lower the risk of eye disease. These medications have also been shown to reduce cardiovascular risks, such as hypertension, and improve circulation, both of which may benefit eye health.

For patients beginning GLP-1 treatment, she advised proactive monitoring. "We should take precaution with methodical ophthalmic care for diabetics on these drugs," she said. "However, let’s not throw the baby out with the bath water."

Ashley Brissette, M.D., an ophthalmologist in New York City, echoed that perspective, calling NAION an "extremely rare" but serious medical condition. She emphasized that the risk associated with GLP-1 drugs is also “extremely rare, at a risk of about one in 10,000, according to other studies.”

"I think caution with anything is warranted," Brissette told Fox News Digital. "And remember these are associations, not causations, so it's not to say that GLP-1 use causes NAION or worsening retinopathy, but their use is associated with these conditions."

She underscored the importance of thorough eye care: "From an ophthalmologic standpoint, these findings underscore the importance of baseline and follow-up eye examinations for patients starting GLP-1 therapy, especially those with pre-existing retinal or optic nerve risk factors."

Brissette added that while the benefits of GLP-1 drugs in reducing cardiovascular and metabolic risks are “substantial,” patients should be counseled on potential vision-related side effects, and “any sudden visual symptoms should prompt immediate ophthalmic referral.”

When contacted by <em>Fox News Digital</em>, Novo Nordisk, the maker of Ozempic and Wegovy, said it stands by the safety of its medications.

"Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from the use of our medicines very seriously. NAION is a very rare eye disease, and it is not an adverse drug reaction for the marketed formulations of semaglutide (Ozempic, Rybelsus and Wegovy) as per the approved labels in the U.S."

The company added: "Novo Nordisk, on its part, has conducted an analysis across randomized controlled clinical trials with GLP-1 receptor agonists, including a blinded ophthalmologist evaluation to confirm NAION diagnoses. Our current assessment is that these data do not suggest a causal relationship between GLP-1 RA use and NAION events."

ozempic lawsuit

weight loss drugs cause vision loss

popular weight loss drugs cause vision loss

semaglutide cause vision loss

Ozempic Lawsuit: "This week's study doesn't suggest that GLP-1 cause your eyes to fall out exactly, but, as you will see in a second, it is not that far off," says Dr F Perry Wilson, MD, MSCE, physician, researcher, educator, and writer, at Yale School of Medicine, before he begins to explain what the new study suggests of the side effects. Weight loss drugs have gained popularity up recently. The popularity is for all the right, and the wrong reasons too. While up recently, we have Wegovy being approved for treating MASH, we also have unheard side effects of the popular drug Ozempic, and not to mention, the cases of pancreatitis reported in the UK, and the ongoing lawsuit on Ozempic.So, what does this new study add to all this?Weight Loss Medication And Vision LossTwo studies, published in JAMA, analyzed how semaglutide, an injection used to treat type 2 diabetes that helps control your blood sugar, and tirzepatide, an antidiabeteic medication, also used to treat type 2 diabetes and for weight loss, administering via injections, which include popular drugs like Ozempic, Wegovy, Mounjaro and Zepbound, impacted eye health in Americans with type 2 diabetes over a 2-year period.What Did The Study Find?One of the studies found a modest risk of developing a non-arteritis anterior ischaemic optic neuropathy (NAOIN), which is a rare eye condition that can lead to sudden vision loss due to lack of blood flow. This condition has close links with the consumption of semaglutide and tirzepatide.Out of more than 159,000 participants with type 2 diabetes, 35 developed NAION, compared to 19 people in the comparison group. The Ohio-based researchers also noted an increased risk of developing "other optic nerve disorders" identified in 93 patients. The second study found no statistically significant link between GLP-1 drug use and NAION, a rare eye condition, but reported a slight uptick in cases of diabetic retinopathy, a retinal disease that can cause vision loss.The study observed that individuals with type 2 diabetes who were treated with GLP-1 drugs faced a modestly higher risk of developing diabetic retinopathy. However, researchers emphasized that fewer patients progressed to sight-threatening stages of the disease. They concluded that all patients with type 2 diabetes receiving GLP-1 therapies should undergo regular screening and monitoring for potential eye complications, regardless of whether they already have diabetic retinopathy."These findings suggest that all patients with type 2 diabetes treated with GLP-1 RAs, regardless of preexisting diabetic retinopathy, should be regularly screened and monitored for potential complications," the study authors concluded.What Are The Experts Saying?As questions continue to mount about the potential connection between GLP-1 weight-loss drugs and vision problems, experts stress that more research is needed before drawing firm conclusions.Sue Decotiis, M.D., a medical weight-loss doctor in New York City, said she believes additional studies are required to confirm whether the drugs increase the risk of vision loss, pointing to conflicting findings so far."NAION is a rare condition of the optic nerve that, although serious, has not really been shown to be increased by these studies," Decotiis, who was not involved in the research, told Fox News Digital. "We need more studies for certain."She noted that diabetic patients already face a heightened risk of eye disease due to blood flow and nerve damage. "Eye complications are often directly related to the degree or lack thereof of diabetes control," she explained.According to Decotiis, GLP-1 drugs often help reduce the severity of type 2 diabetes, which can in turn lower the risk of eye disease. These medications have also been shown to reduce cardiovascular risks, such as hypertension, and improve circulation, both of which may benefit eye health.For patients beginning GLP-1 treatment, she advised proactive monitoring. "We should take precaution with methodical ophthalmic care for diabetics on these drugs," she said. "However, let’s not throw the baby out with the bath water."Ashley Brissette, M.D., an ophthalmologist in New York City, echoed that perspective, calling NAION an "extremely rare" but serious medical condition. She emphasized that the risk associated with GLP-1 drugs is also “extremely rare, at a risk of about one in 10,000, according to other studies.”"I think caution with anything is warranted," Brissette told Fox News Digital. "And remember these are associations, not causations, so it's not to say that GLP-1 use causes NAION or worsening retinopathy, but their use is associated with these conditions."She underscored the importance of thorough eye care: "From an ophthalmologic standpoint, these findings underscore the importance of baseline and follow-up eye examinations for patients starting GLP-1 therapy, especially those with pre-existing retinal or optic nerve risk factors."Brissette added that while the benefits of GLP-1 drugs in reducing cardiovascular and metabolic risks are “substantial,” patients should be counseled on potential vision-related side effects, and “any sudden visual symptoms should prompt immediate ophthalmic referral.”When contacted by Fox News Digital, Novo Nordisk, the maker of Ozempic and Wegovy, said it stands by the safety of its medications."Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from the use of our medicines very seriously. NAION is a very rare eye disease, and it is not an adverse drug reaction for the marketed formulations of semaglutide (Ozempic, Rybelsus and Wegovy) as per the approved labels in the U.S."The company added: "Novo Nordisk, on its part, has conducted an analysis across randomized controlled clinical trials with GLP-1 receptor agonists, including a blinded ophthalmologist evaluation to confirm NAION diagnoses. Our current assessment is that these data do not suggest a causal relationship between GLP-1 RA use and NAION events."

Tanya Dutt

Nasal Spray That 'Works In Hours' May Replace Pills For Depression Treatment

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A breakthrough study finds esketamine nasal spray may deliver meaningful improvement for treatment-resistant depression within hours. For decades, patients struggling with major depressive disorder (MDD) have had to wait weeks sometimes months for antidepressant medications to show effects. For roughly one in three people, even after trying multiple drugs, relief never comes. This group, known as treatment-resistant depression (TRD), faces limited and often frustrating options.

Now, a new clinical trial suggests there may be another path, esketamine nasal spray. Researchers report that when used as a standalone treatment, esketamine provided rapid and sustained relief for adults with TRD. Unlike traditional antidepressants that take weeks to work, improvements appeared within 24 hours and lasted throughout the study’s four-week duration. The findings were published in JAMA Psychiatry.

Ketamine, a compound first approved in the 1970s as an anesthetic, has drawn increasing attention for its antidepressant effects at lower doses. Esketamine, a chemically refined version, works on similar pathways but is more targeted.

In 2019, the U.S. Food and Drug Administration approved SPRAVATO, an esketamine nasal spray, for use alongside oral antidepressants in TRD. Until now, it was unclear whether the spray could stand on its own. This new phase 4 trial offers the strongest evidence yet that esketamine may be effective without an added oral drug.

The study enrolled 378 adults across 51 U.S. outpatient centers between 2020 and 2024. To qualify, participants had to show a history of poor response—defined as less than 25% improvement—to at least two antidepressants during their current depressive episode.

Design: randomized, double-blind, placebo-controlled

Groups: fixed doses of either 56 mg or 84 mg esketamine, or a placebo spray

Treatment schedule: twice-weekly dosing for four weeks

Primary measure: changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores, which capture depression severity

Most participants were women (61%), and the average age was 45. All entered the study with moderate-to-severe depression.

<h2>How Esketamine Nasal Spray Works?</h2>

Within a single day of treatment, both esketamine groups reported noticeable improvements compared to placebo. By day 28, those on 56 mg showed a 5.1-point greater reduction in symptom scores versus placebo.

The 84 mg group had an even stronger effect, with a 6.8-point advantage. For perspective, traditional antidepressants often take six to eight weeks to yield measurable changes. Esketamine’s speed is one of the factors making it so promising for TRD patients, many of whom live with intense, persistent distress.

Patients who continued into the optional 12-week open-label phase—where all participants received esketamine—maintained or further improved their scores. This suggests the drug’s benefits may extend beyond the initial four weeks.

The “number needed to treat,” a measure of clinical significance, was around 6–7 for symptom response. This means that for every six or seven patients treated, at least one more experienced a meaningful reduction in depression compared to placebo. For a psychiatric intervention, that is a robust effect size.

<h2>Are There Any Side Effects of the Nasal Spray?</h2>

Like other ketamine-based therapies, esketamine is not without side effects. In this trial, the most common were nausea, dizziness, headache, and dissociation, a temporary feeling of detachment from one’s surroundings.

Importantly, these effects were short-lived, generally resolving within hours of dosing. Safety monitoring also showed no increase in suicidal thinking compared to placebo, an encouraging finding in depression research. No treatment-related deaths were reported.

Still, the psychoactive nature of the drug meant some participants could guess whether they had received esketamine or placebo, a limitation that researchers acknowledged.

For the estimated 280 million people worldwide living with major depressive disorder, and especially the one-third who don’t respond to conventional drugs, esketamine represents a potential paradigm shift.

Traditional antidepressants work by altering serotonin, norepinephrine, or dopamine. Esketamine instead targets the glutamate system, offering a novel mechanism of action. That difference matters- before SPRAVATO, psychiatry hadn’t seen a new treatment pathway in over 30 years.

Adam Janik, medical director at Johnson &amp; Johnson and lead author of the study, emphasized the scale of the problem: “The size and scope of the global depression epidemic is staggering. Significant unmet needs remain for these patients.”

While the findings are promising, experts caution against premature conclusions. The trial population was not racially diverse, and individuals with certain psychiatric conditions were excluded. That raises questions about how well the results will apply across broader patient groups.

For decades, patients with treatment-resistant depression have cycled through medications, therapies, and hospitalizations, often with little relief. This study adds weight to a growing body of evidence that esketamine could break that cycle. While it is not a cure, the possibility of meaningful relief within hours rather than weeks could be life-changing for millions.

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antidepressant nasal spray

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fast acting antidepressant

non oral depression treatment

A breakthrough study finds esketamine nasal spray may deliver meaningful improvement for treatment-resistant depression within hours. For decades, patients struggling with major depressive disorder (MDD) have had to wait weeks sometimes months for antidepressant medications to show effects. For roughly one in three people, even after trying multiple drugs, relief never comes. This group, known as treatment-resistant depression (TRD), faces limited and often frustrating options.Now, a new clinical trial suggests there may be another path, esketamine nasal spray. Researchers report that when used as a standalone treatment, esketamine provided rapid and sustained relief for adults with TRD. Unlike traditional antidepressants that take weeks to work, improvements appeared within 24 hours and lasted throughout the study’s four-week duration. The findings were published in JAMA Psychiatry.Ketamine, a compound first approved in the 1970s as an anesthetic, has drawn increasing attention for its antidepressant effects at lower doses. Esketamine, a chemically refined version, works on similar pathways but is more targeted.In 2019, the U.S. Food and Drug Administration approved SPRAVATO, an esketamine nasal spray, for use alongside oral antidepressants in TRD. Until now, it was unclear whether the spray could stand on its own. This new phase 4 trial offers the strongest evidence yet that esketamine may be effective without an added oral drug.The study enrolled 378 adults across 51 U.S. outpatient centers between 2020 and 2024. To qualify, participants had to show a history of poor response—defined as less than 25% improvement—to at least two antidepressants during their current depressive episode.Key features of the trial included:Design: randomized, double-blind, placebo-controlledGroups: fixed doses of either 56 mg or 84 mg esketamine, or a placebo sprayTreatment schedule: twice-weekly dosing for four weeksPrimary measure: changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores, which capture depression severityMost participants were women (61%), and the average age was 45. All entered the study with moderate-to-severe depression.How Esketamine Nasal Spray Works?Within a single day of treatment, both esketamine groups reported noticeable improvements compared to placebo. By day 28, those on 56 mg showed a 5.1-point greater reduction in symptom scores versus placebo.The 84 mg group had an even stronger effect, with a 6.8-point advantage. For perspective, traditional antidepressants often take six to eight weeks to yield measurable changes. Esketamine’s speed is one of the factors making it so promising for TRD patients, many of whom live with intense, persistent distress.Patients who continued into the optional 12-week open-label phase—where all participants received esketamine—maintained or further improved their scores. This suggests the drug’s benefits may extend beyond the initial four weeks.The “number needed to treat,” a measure of clinical significance, was around 6–7 for symptom response. This means that for every six or seven patients treated, at least one more experienced a meaningful reduction in depression compared to placebo. For a psychiatric intervention, that is a robust effect size.Are There Any Side Effects of the Nasal Spray?Like other ketamine-based therapies, esketamine is not without side effects. In this trial, the most common were nausea, dizziness, headache, and dissociation, a temporary feeling of detachment from one’s surroundings.Importantly, these effects were short-lived, generally resolving within hours of dosing. Safety monitoring also showed no increase in suicidal thinking compared to placebo, an encouraging finding in depression research. No treatment-related deaths were reported.Still, the psychoactive nature of the drug meant some participants could guess whether they had received esketamine or placebo, a limitation that researchers acknowledged.For the estimated 280 million people worldwide living with major depressive disorder, and especially the one-third who don’t respond to conventional drugs, esketamine represents a potential paradigm shift.Traditional antidepressants work by altering serotonin, norepinephrine, or dopamine. Esketamine instead targets the glutamate system, offering a novel mechanism of action. That difference matters- before SPRAVATO, psychiatry hadn’t seen a new treatment pathway in over 30 years.Adam Janik, medical director at Johnson & Johnson and lead author of the study, emphasized the scale of the problem: “The size and scope of the global depression epidemic is staggering. Significant unmet needs remain for these patients.”While the findings are promising, experts caution against premature conclusions. The trial population was not racially diverse, and individuals with certain psychiatric conditions were excluded. That raises questions about how well the results will apply across broader patient groups.For decades, patients with treatment-resistant depression have cycled through medications, therapies, and hospitalizations, often with little relief. This study adds weight to a growing body of evidence that esketamine could break that cycle. While it is not a cure, the possibility of meaningful relief within hours rather than weeks could be life-changing for millions.

nasal spray that 'works in hours' may replace pills for depression treatment

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Invasive New Tick Species Could Spread Little-Known Infectious Disease, Scientists Warn

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Two of the premature infants, each weighing under two pounds, succumbed within days of one another at San Maurizio Hospital in Bolzano, <span>Italy</span>. The probable cause: Serratia marcescens, a bacterium traced to detergent dispensers used to wash baby bottles and teats in the neonatal intensive care unit (NICU).

The two premature infants, born at 23 and 27 weeks of gestation, died from overwhelming sepsis on August 12 and 13. Both deaths have raised serious questions about the hospital's infection control and hygiene practices, as well as the exceptional vulnerability of premature infants.

Italy's National Anti-Corruption and Prevention Agency (NAS) is spearheading the investigation into how a kitchen staple—dishwashing detergent—was used as a lethal vector. Preliminary tests isolated Serratia marcescens in the spout and dispensers utilized for the soap reservoir in the NICU. Authorities are investigating several alternatives:

<ol><li>The detergent could have been contaminated during transport to the hospital.</li><li>Improper storage or handling could have provided an environment for bacteria to flourish.</li><li>An infected person may have transferred the pathogen through contact with the dispenser.</li></ol>

The route of contamination is uncertain until laboratory tests are done.

Serratia marcescens is no stranger to hospitals. The bacteria exist best in damp surroundings—sinks, soap dispensers, catheters—and though usually harmless to healthy patients, are deadly to those with weakened immune systems. For preemies, whose immune systems are still developing, contact can rapidly degenerate into sepsis, pneumonia, or meningitis.

Hospital administrator Pierpaolo Bertoli emphasized that the germ itself was not novel. "The bacterium's presence is not singular because it is always a threat to neonatal intensive care units," he stated. The threat, he continued, is in the immense vulnerability of NICU patients.

<h2>Immediate Response and Precautionary Measures</h2>

After the discovery, a recall of all soap from the Bolzano hospital system was ordered, and admission of no more high-risk premature infants is taking place until notice. Existing cases are being routed to hospitals in Trento, about 40 miles away.

The hospital has even transferred the 10 remaining NICU babies to a different wing as a precautionary step. The hospital's medical director, Dr. Monika Zaebisch, confirmed that proper hygiene procedures were in effect but accepted the tragedy. "Unfortunately, these two cases could not be prevented," she stated.

<h2>Why Premature Babies Are Susceptible To Deadly Infections</h2>

Prematurity, or delivery prior to 37 weeks, leaves babies with a poorly developed immune system. Under normal circumstances, transfer of protective antibodies from the mother through the placenta in the third trimester supplies babies with at least partial immunity at birth. In preemies, that all-important exchange is incomplete—or nonexistent.

This absence of maternal immunity, coupled with medical interventions like catheters, ventilators, and feeding tubes, provides an entry point for bacteria such as Serratia marcescens. Infections that would be contained within older children or adults—such as bloodstream infections, pneumonia, or meningitis—can develop quickly and be life-threatening in preterm infants.

The Bolzano tragedy is no lone wolf. Hospitals around the globe have experienced outbreaks attributed to contaminated medical devices, water supply lines, and cleaning solutions. Even slight breaches of sterilization procedures can snowball into fatal infections in vulnerable wards such as NICUs.

Dr. Josef Widmann, director of medicine for the South Tyrolean Health Authority, recognized the systemwide problem. "This is not merely one product issue," he told a press briefing. "It is a reminder that NICUs remain under constant risk of microbial exposure.

The incident comes on the heels of another Italian public health crisis: a botulism outbreak from a food vendor in southwest Italy that resulted in two deaths and sent 14 to the hospital. Combined, the incidents highlighted systemic weaknesses in food and health safety regulation.

The Public Prosecutor of Bolzano is contemplating autopsies on the infants, which would determine whether charges of malpractice were appropriate. Relatives and health advocates are demanding answers, both to pay respects to those who died and to guarantee system change.

In the meantime, NAS researchers persist in testing the recalled detergent, dispenser units, and environmental swabs from the NICU. Identification of where the contamination took place, at the production facility, in storage, or within the hospital system itself, is important not only for legal accountability but also for avoiding future such outbreaks.

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Two of the premature infants, each weighing under two pounds, succumbed within days of one another at San Maurizio Hospital in Bolzano, Italy. The probable cause: Serratia marcescens, a bacterium traced to detergent dispensers used to wash baby bottles and teats in the neonatal intensive care unit (NICU).The two premature infants, born at 23 and 27 weeks of gestation, died from overwhelming sepsis on August 12 and 13. Both deaths have raised serious questions about the hospital's infection control and hygiene practices, as well as the exceptional vulnerability of premature infants.Italy's National Anti-Corruption and Prevention Agency (NAS) is spearheading the investigation into how a kitchen staple—dishwashing detergent—was used as a lethal vector. Preliminary tests isolated Serratia marcescens in the spout and dispensers utilized for the soap reservoir in the NICU. Authorities are investigating several alternatives:The detergent could have been contaminated during transport to the hospital.Improper storage or handling could have provided an environment for bacteria to flourish.An infected person may have transferred the pathogen through contact with the dispenser.The route of contamination is uncertain until laboratory tests are done.What Is Serratia marcescens?Serratia marcescens is no stranger to hospitals. The bacteria exist best in damp surroundings—sinks, soap dispensers, catheters—and though usually harmless to healthy patients, are deadly to those with weakened immune systems. For preemies, whose immune systems are still developing, contact can rapidly degenerate into sepsis, pneumonia, or meningitis.Hospital administrator Pierpaolo Bertoli emphasized that the germ itself was not novel. "The bacterium's presence is not singular because it is always a threat to neonatal intensive care units," he stated. The threat, he continued, is in the immense vulnerability of NICU patients.Immediate Response and Precautionary MeasuresAfter the discovery, a recall of all soap from the Bolzano hospital system was ordered, and admission of no more high-risk premature infants is taking place until notice. Existing cases are being routed to hospitals in Trento, about 40 miles away.The hospital has even transferred the 10 remaining NICU babies to a different wing as a precautionary step. The hospital's medical director, Dr. Monika Zaebisch, confirmed that proper hygiene procedures were in effect but accepted the tragedy. "Unfortunately, these two cases could not be prevented," she stated.Why Premature Babies Are Susceptible To Deadly InfectionsPrematurity, or delivery prior to 37 weeks, leaves babies with a poorly developed immune system. Under normal circumstances, transfer of protective antibodies from the mother through the placenta in the third trimester supplies babies with at least partial immunity at birth. In preemies, that all-important exchange is incomplete—or nonexistent.This absence of maternal immunity, coupled with medical interventions like catheters, ventilators, and feeding tubes, provides an entry point for bacteria such as Serratia marcescens. Infections that would be contained within older children or adults—such as bloodstream infections, pneumonia, or meningitis—can develop quickly and be life-threatening in preterm infants.The Bolzano tragedy is no lone wolf. Hospitals around the globe have experienced outbreaks attributed to contaminated medical devices, water supply lines, and cleaning solutions. Even slight breaches of sterilization procedures can snowball into fatal infections in vulnerable wards such as NICUs.Dr. Josef Widmann, director of medicine for the South Tyrolean Health Authority, recognized the systemwide problem. "This is not merely one product issue," he told a press briefing. "It is a reminder that NICUs remain under constant risk of microbial exposure.The incident comes on the heels of another Italian public health crisis: a botulism outbreak from a food vendor in southwest Italy that resulted in two deaths and sent 14 to the hospital. Combined, the incidents highlighted systemic weaknesses in food and health safety regulation.The Public Prosecutor of Bolzano is contemplating autopsies on the infants, which would determine whether charges of malpractice were appropriate. Relatives and health advocates are demanding answers, both to pay respects to those who died and to guarantee system change.In the meantime, NAS researchers persist in testing the recalled detergent, dispenser units, and environmental swabs from the NICU. Identification of where the contamination took place, at the production facility, in storage, or within the hospital system itself, is important not only for legal accountability but also for avoiding future such outbreaks.

two premature infants die from infection in italy hospital over suspected soap dish contamination

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