New Drug Indication for Patients With Depression Could Be Life-Changing

NEWS BRIEF

The Food and Drug Administration has approved a supplemental new drug application (sNDA) for esketamine (Spravato) CIII nasal spray to treat major depressive disorder (MDD). Taken with an oral antidepressant, esketamine is now approved for symptoms of MDD in patients with acute suicidal ideation or behaviors.

In light of speculation that greater numbers of persons will experience suicidal ideation as a result of the COVID-19 pandemic, the FDA approval “means the quick-acting nasal spray will be available to people with suicidal thoughts and a plan to put them into action,” said Michelle Kramer, vice president of Johnson & Johnson neuroscience medical-affairs unit.¹

Since the FDA approved esketamine in 2019 for treatment-resistant depression (TRD), approximately 6000 patients have been prescribed the medication. Now approved for treating MDD in adults, esketamine “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.”² According to a Janssen press release:

“With this new indication, SPRAVATO® can be prescribed to treat depressive symptoms in two MDD subpopulations of adults with high unmet need:

•TRD, which the FDA approved on March 5, 2019, and

•MDD with acute suicidal ideation or behavior.

A full course of treatment for the new indication is twice weekly for four weeks, after which evidence of therapeutic benefit should be evaluated to determine need for continued treatment.”³

Gerard Sanacora, MD, PhD,³ director of the Yale Depression Research Program, New Haven, CT, and esketamine clinical trial investigator, states, "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.”

References

1. Koons C. Johnson & Johnson Spray Approved to Treat Suicidal People. Bloomberg. August 3, 2020. Accessed August 4, 2020. https://www.bloomberg.com/news/articles/2020-08-03/johnson-johnson-spray-approved-for-treating-suicidal-people

2. SPRAVATO® [Prescribing Information]. Titusville, NJ. Janssen Pharmaceuticals, Inc. Accessed August 4, 2020. http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf

3. Janssen Announces U.S. FDA Approval of SPRAVATO® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior [press release]. Janssen Pharmaceuticals. August 3, 2020. Accessed August 4, 2020. https://www.prnewswire.com/news-releases/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-301104437.html