FDA Panel Supports New 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.

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.

—Michael Potts

Reference:

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.