FDA Committee Endorses Nasal Spray for Depression
An FDA Advisory Committee has voted 14 to 2 that the benefits of Spravato (esketamine) nasal spray for treatment-resistant depression outweigh the risks.
If approved, the drug would provide the first new mechanism of action for the treatment of major depressive disorder in 30 years.
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The committee based their decision on safety and efficacy data from 5 Phase 3 studies involving patients with treatment-resistant depression. Three of the studies were short-term, 1 was a maintenance of effect study, and 1 was a long-term safety study. Supportive data was provided by the Spravato research program, which included data from 3 Phase 2 studies and 19 Phase 1 studies.
Data from the Phase 3 studies demonstrated that esketamine plus newly initiated oral antidepressant provided significant and sustained improvement of depressive symptoms. The long-term safety study revealed that esketamine was generally tolerable and had no new safety signals with dosing up to 52 weeks compared with data from short-term studies.
Treatment-emergent effects included dissociative symptoms, dizziness/vertigo, increased blood pressure, and sedation. Most of these effects occurred shortly after dosing and while patients were still under supervision of a health care professional. Most also resolved the same day.
FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression [press release]. Titusville, New Jersey. February 12, 2019. https://www.prnewswire.com/news-releases/fda-advisory-committee-recommends-approval-of-spravato-esketamine-nasal-spray-ciii-for-adults-with-treatment-resistant-depression-300794493.html.