J&J seeks FDA approval of esketamine as monotherapy for treatment-resistant depression

Key takeaways:

• If this indication of esketamine is approved, it would be the first monotherapy for treatment-resistant depression.
• Phase 4 data showed esketamine monotherapy improved symptoms in as early as 24 hours.

Johnson & Johnson announced that it has submitted a supplemental new drug application for the approval of esketamine nasal spray as a monotherapy for adults with treatment-resistant depression.

If approved, esketamine nasal spray (Spravato, Janssen Pharmaceuticals) would be the first monotherapy for treatment-resistant depression in the United States, according to a company press release.

The supplemental new drug application includes data from a phase 4 randomized, double-blind, multicenter, placebo-controlled trial that showed esketamine reduced symptoms as early as 24 hours after the first dose, the release said. This improvement was sustained for at least 4 weeks.

Esketamine, a variation of a ketamine treatment, has been available since 2019. It is currently approved in the U.S. for use in combination with oral antidepressant medication for adults with treatment-resistant depression and adults with major depressive disorder with suicidal ideation or behavior, according to the release.

There are safety concerns with esketamine. It has been linked to risks for sedation, dissociation, respiratory depression and abuse and misuse, the release said. Due to these concerns, esketamine is only available through the Risk Evaluation and Mitigation Strategy (REMS) program, meaning it can only be administered at REMS-certified health care facilities.

In the recent phase 4 trial, J&J said “no new safety concerns were identified.”

“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” Bill Martin, PhD, global therapeutic area head of neuroscience at J&J Innovative Medicine, said in the release. “We’re pleased to build on the more than a decade of research reinforcing the safety and efficacy of Spravato and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option.”