FDA Advisory Committee Recommends Approval of Nasal Spray for Treatment-Resistant Depression

FEBRUARY 12, 2019
An FDA Advisory Committee has recommended the agency’s approval of Janssen’s esketamine nasal spray CIII (Spravato) for adults living with treatment-resistant depression. Officials with the FDA may make a decision on the medication next month, according to a press release from Janssen and its parent company Johnson & Johnson.

The FDA Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted with 14 in favor of the data supporting the favorable benefit-risk profile of esketamine nasal spray CIII for its indicated use. Two members of the committees voted ‘no,’ and 1 member abstained from the vote.

"We are pleased with the advisory committees' vote and their recommendation to approve Spravato as a potential therapy for adults living with treatment-resistant depression," said Husseini K. Manji, M.D., Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, in a prepared statement. "Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression."

Janssen’s esketamine product is an investigational prescription treatment that is thought to work differently than currently approved therapies for major depressive disorder.

The company announced September 4, 2018 that it had submitted a New Drug Application (NDA) to the FDA for the approval of Spravato. If approved, the drug would provide the first new mechanism of action in 30 years to treat this mental illness.

The voting committees based support on safety and efficacy data from 5 Phase 3 studies in patients with treatment-resistant depression: 3 short-term studies; 1 maintenance of effect study; and 1 long-term safety study. In addition, the research program for the drug provided supportive data from 3 Phase 2 studies and 19 Phase 1 studies in patients with treatment-resistant depression and healthy volunteers. Data from both a short-term Phase 3 study and a long-term Phase 3 study demonstrated that esketamine nasal spray plus a newly initiated oral antidepressant provided statistically significant, clinically meaningful, rapid, and sustained improvement of depressive symptoms in this difficult-to-treat population. 

All patients who participated in the Phase 3 studies received esketamine or placebo, in addition to a newly initiated oral antidepressant at the start of the treatment phase.

The long-term safety study showed that esketamine was generally tolerable, with no new safety signals with dosing up to 52 weeks compared to data from short-term (4-week) studies. Discontinuation rates due to esketamine-related adverse events were low and occurred typically in the first weeks.

Most treatment-emergent adverse events, including dissociative symptoms, dizziness or vertigo, increased blood pressure, and sedation, occurred shortly after dosing while patients were under the supervision of a health care professional, were transient, and resolved the same day. In addition to the comprehensive clinical research program, the company proposed a robust Risk Evaluation and Mitigation Strategy.


Reference

FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression [news release]. Titusville, New Jersey; February 12, 2019: Janssen website. https://www.janssen.com/fda-advisory-committee-recommends-approval-spravato-esketamine-nasal-spray-ciii-adults-treatment. Accessed February 2019. 

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