FDA Approved Esketamine Nasal Spray for Major Depressive Dis
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US Food and Drug Administration 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 new indication is based on data from two identical phase 3 trials — ASPIRE I and ASPIRE II — which evaluated the efficacy and safety.

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.

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

Source: https://www.janssen.com/janssen-announces-us-fda-approval-spravator-esketamine-ciii-nasal-spray-treat-depressive-symptoms
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