New Drug Indication for Patients With Depression Could Be Life-Changing
Taken with an oral antidepressant, esketamine is now approved to treat symptoms of MDD in patients with acute suicidal ideation or behaviors.
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
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
“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
References
1. Koons C. Johnson & Johnson Spray Approved to Treat Suicidal People. Bloomberg. August 3, 2020. Accessed August 4, 2020.
2. SPRAVATO® [Prescribing Information]. Titusville, NJ. Janssen Pharmaceuticals, Inc. Accessed August 4, 2020.