FDA Okays New Indication for Esketamine Nasal Spray

Megan Brooks

August 03, 2020

The US Food and Drug Administration (FDA) has approved the supplemental new drug application for esketamine nasal spray (Spravato, Janssen Pharmaceuticals) to treat depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior.

The FDA approved esketamine nasal spray for treatment-resistant depression in March 2019, as reported by Medscape Medical News.

The new indication is based on data from two identical phase 3 trials — ASPIRE I and ASPIRE II — which evaluated the efficacy and safety of the nasal spray in addition to a comprehensive standard of care in adults with MDD who had active suicidal ideation with intent.

The standard of care included initial hospitalization, a newly initiated or optimized oral antidepressant, and twice-weekly treatment visits for 4 weeks. During that time, patients received esketamine nasal spray 84 mg or placebo nasal spray.

Results from the trials showed that the active treatment significantly reduced depressive symptoms within 24 hours, with some patients starting to respond as early as 4 hours after the first dose.

"Traditional oral antidepressants need weeks or more to take effect, so the availability of a medicine that can begin providing relief within a day is potentially life changing," Theresa Nguyen, chief program officer, Mental Health America, said in a company news release.

"The clinical trials supporting this new indication provide compelling evidence that esketamine may offer clinicians a new way to provide support to patients quickly in the midst of an urgent depressive episode and help set them on the path to remission," Gerard Sanacora, MD, PhD, director of the Yale Depression Research Program, New Haven, Connecticut, and esketamine clinical trial investigator, said in the same release.

A full course of treatment for MDD with acute suicidal ideation or behavior is twice weekly for 4 weeks, "after which evidence of therapeutic benefit should be evaluated to determine need for continued treatment," the company said.

Due to the risk for serious adverse events, including sedation and dissociation, and the potential for abuse or misuse, esketamine nasal spray is only available through a restricted distribution system — the Spravato Risk Evaluation and Mitigation Strategy (REMS).

The patient self-administers esketamine nasal spray only in REMS-certified healthcare settings. Patients are not permitted to take the drug home.

Full prescribing information is available online.

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