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Tag: antidepressant
FDA allows standalone use of nasal spray antidepressant Spravato (esketamine) : Shots
Spravato, the brand name for esketamine, has a newly approved indication for treatment-resistant depression.
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The U.S. Food and Drug Administration has expanded its approval of Spravato, an antidepressant nasal spray. The drug is now cleared for use as a standalone treatment for depression.
Spravato is made from esketamine, one of two mirror-image molecules found in the anesthetic ketamine. It was approved in 2019 for use in adults with major depressive disorder who did not respond to at least two other antidepressants.
The original approval required that patients on Spravato also receive an oral antidepressant. Now, the FDA says the drug can be used on its own. The decision came after a large study found that Spravato alone worked better than a placebo. In the first nine months of 2024, the drug generated sales of about $780 million for its maker, Johnson & Johnson.
Spravato is intended to be administered under the direct supervision of a healthcare provider.
In the company’s press release announcing the expanded use, it stressed that depression is complicated and the drug could cause, “serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse,” so it will continue to be administered in certified treatment centers.
Major depressive disorder affects more than 20 million adults in the U.S. About one in three patients does not respond to oral antidepressants alone.
The Food and Drug Administration (FDA) has recently approved the standalone use of the nasal spray antidepressant Spravato (esketamine). This groundbreaking decision allows patients to access this innovative treatment option without the need for additional medications or therapies.Spravato, which contains the active ingredient esketamine, has shown promising results in clinical trials for treating treatment-resistant depression. By targeting the brain’s glutamate receptors, esketamine works differently from traditional antidepressants, providing a new approach to managing depression.
This approval marks a significant step forward in mental health treatment, offering patients a convenient and effective option for managing their symptoms. The standalone use of Spravato provides a streamlined approach to treatment, making it more accessible for those in need.
If you or a loved one are struggling with depression, talk to your healthcare provider about the possibility of incorporating Spravato into your treatment plan. With the FDA’s approval of standalone use, this nasal spray antidepressant could be a game-changer in the field of mental health.
Tags:
- FDA approval
- Nasal spray antidepressant
- Spravato
- Esketamine
- Standalone use
- Mental health
- Depression treatment
- FDA regulation
- Drug approval
- Innovative treatment options
#FDA #standalone #nasal #spray #antidepressant #Spravato #esketamine #Shots
Neumora’s antidepressant stumbles in first Phase 3 trial readout
A new depression treatment developed by startup Neumora Therapeutics failed in a Phase 3 clinical trial — the company’s first late-stage readout.Â
The drug, navacaprant, failed to show a meaningful improvement in depression scores compared to placebo, the company reported Thursday. Both the treatment group and the placebo group reported a 12.5-point reduction in their scores. The drug also failed to show a statistically significant improvement on a scoring system measuring participants’ ability to experience pleasure, when compared to placebo.
This is the first of three Phase 3 studies that Neumora has planned for navacaprant.Â
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Neumora’s antidepressant fails to show efficacy in Phase 3 trialIn a disappointing turn of events, Neumora’s highly anticipated antidepressant has stumbled in its first Phase 3 trial readout. The drug, which was expected to provide a new treatment option for patients with major depressive disorder, failed to show significant efficacy compared to placebo.
The results have come as a blow to Neumora, which had high hopes for the drug based on promising earlier stage trials. The company now faces the difficult task of regrouping and determining the next steps for the development of the drug.
Investors and patients alike are left disappointed by the news, as the need for new and effective treatments for depression remains high. Neumora’s setback serves as a reminder of the challenges and uncertainties inherent in drug development, and underscores the importance of continued research and innovation in the field of mental health.
It remains to be seen what the future holds for Neumora’s antidepressant, but for now, the road ahead looks uncertain.
Tags:
- Neumora antidepressant
- Phase 3 trial
- Neumora drug trial results
- Antidepressant medication
- Neumora clinical trial update
- Mental health treatment
- Depression medication
- Pharmaceutical research
- Neumora drug development
- Antidepressant effectiveness
#Neumoras #antidepressant #stumbles #Phase #trial #readout
