FDA committees support esketamine nasal spray for treatment-resistant depression
In a joint meeting, the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee recommended the approval of esketamine nasal spray CIII for adults with treatment-resistant depression, according to a press release.
The committees voted 14-2, with one abstention, that the data show a favorable benefit-risk profile of esketamine nasal spray (Spravato, Janssen Pharmaceuticals).
In September 2018, Janssen submitted a New Drug Application to the FDA for esketamine.
The committees based their votes on positive data from five phase 3 studies in patients with treatment-resistant depression, which included three short-term studies, a maintenance of effect study and a long-term safety study, according to the release.
Data from the studies demonstrated that treatment with esketamine plus a newly initiated oral antidepressant was linked to rapid reduction of depressive symptoms and delayed time to relapse of symptoms of depression, compared with placebo plus a newly initiated antidepressant. The long-term safety study determined that esketamine was generally tolerable with dosing up to 52 weeks compared with data from short-term studies. Moreover, phase 2 data also supported esketamine for depression.
As for the safety profile, most treatment-emergent adverse events related to esketamine nasal spray occurred shortly after dosing while patients were supervised by a health care professional, were brief and resolved same day, according to the release.
"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," Husseini K. Manji, MD, global head of the neuroscience therapeutic area, Janssen Research & Development, said in the release. "Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression."
The FDA has already granted Breakthrough Therapy Designations for esketamine for treatment-resistant depression and for MDD with imminent risk for suicide.
The Prescription Drug User Fee Act (PDUFA) date for Spravato is March 4, 2019, according to the release.
Disclosure: Manji is an employee of Janssen.