FDA OKs New Indication for Esketamine Nasal Spray

August 5, 2020

Esketamine (Spravato; Janssen) CIII nasal spray is the first FDA-approved antidepressant medication that improves depressive symptoms with the first dose in adults with major depressive disorder.

The FDA approved esketamine (Spravato; Janssen) CIII nasal spray for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.1

Although esketamine CIII nasal spray is already approved to treat depression, the agency okayed Janssen's supplemental new drug application (sNDA), taken with an oral antidepressant, for this patient population.1

“Spravato is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours,providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect,” Janssen said in a press release.1

Janssen garnered criticism after esketamine's original approval last year, because 3 patients who received the drug died by suicide during the clinical trials, “raising red flags Janssen and the FDA dismissed,” Kaiser Health News reported.2

The wholesale acquisition cost (WAC) for esketamine was also controversial at the time. It was reported to be between $2360 and $3540 per course of treatment.2

Janssen also presented “modest” clinical trial data and no information about the safety of esketamine for long-term use beyond 60 weeks to FDA, according to Kaiser Health News.2

However, esketamine carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors, and is available at REMS-certified treatment centers.1

“Janssen is working to responsibly educate and certify treatment centers in accordance with the REMS so health care providers can offer esketamine to appropriate patients,” Janssen said.1

The effectiveness of esketamine in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated, Janssen added.1

The sNDA approval is based on 2 identical phase 3 clinical trials in which esketamine plus comprehensive standard of care demonstrated a significant, rapid reduction of depressive symptoms within 24 hours, with some patients starting to respond as early as 4 hours.1

Esketamine plus comprehensive standard of care led to a 15.9 and 16.0 point decrease on the Montgomery-Åsberg Depression Rating Scale (MADRS) after the first dose of the drug, compared with a reduction of 12.0 and 12.2 points in the placebo plus comprehensive standard of care group.1

This article was originally published on FormularyWatch.com.

References

1. Janssen Announces US FDA Approval of SPRAVATO (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior. News Release. Janssen; August 3, 2020. Accessed August 4, 2020. https://www.janssen.com/janssen-announces-us-fda-approval-spravator-esketamine-ciii-nasal-spray-treat-depressive-symptoms

2. Huetteman E. FDA Overlooked Red Flags in Drugmaker's Testing of New Depression Medicione. Kaiser Health News. Published June 11, 2019. Accessed August 5, 2020. https://khn.org/news/fdas-approval-of-new-depression-drug-overlooked-red-flags-in-its-testing/.