Janssen's Innovative Therapy SPRAVATO® Approved by FDA for Rapid Relief of Depressive Symptoms in Adults with Major Depressive Disorder and Acute Suicidal Ideation or Behavior

Janssen, a Johnson & Johnson company, announced today that the U.S. FDA has approved the supplemental New Drug Application (sNDA) for Spravato® (esketamine) CIII nasal spray, in combination with an oral antidepressant, for the treatment of depressive symptoms in adults with major depressive disorder (MDD) experiencing acute suicidal ideation or behavior. The press release noted that Spravato is the first and only FDA-approved medication demonstrated to reduce depressive symptoms within 24 hours, offering a new option for rapid symptom relief.

Depression is a leading cause of disability worldwide and the most common suicide-related disorder. Major Depressive Disorder (MDD) is a serious illness that exerts significant negative effects on an individual’s thoughts, emotions, and behaviors. Symptoms and severity vary among individuals and may include persistent sadness, hopelessness, or anxiety; changes in sleep or appetite; difficulty concentrating or performing activities of daily living; loss of interest; and/or thoughts of self-harm.

Spravato nasal spray is a non-selective, non-competitive NMDA receptor antagonist. It has a novel mechanism of action that differs from currently available antidepressant medications. Last year, it received FDA approval for the treatment of adult patients with treatment-resistant depression (TRD).

The approval of this indication was based on two identical Phase 3 clinical trials, which demonstrated that Spravato, in combination with comprehensive standard care, significantly and rapidly alleviated depressive symptoms within 24 hours. Some patients began to respond as early as 4 hours after administration. In both trials, at 24 hours post-dose, Spravato plus comprehensive standard care resulted in reductions of 15.9 and 16.0 points, respectively, on the Montgomery-Åsberg Depression Rating Scale (MADRS), a tool used to assess the severity of depressive symptoms. In contrast, the placebo plus comprehensive standard care groups showed reductions of 12.0 and 12.2 points, respectively.

Patients in the Spravato and placebo groups experienced sustained symptom improvement from 4 hours to 25 days post-dose. In two trials, 41% and 43% of patients in the Spravato group achieved clinical remission of depression (minimal or no symptoms), compared with 34% and 27% in the placebo group at the end of the double-blind phase.

“Many people with depression are all too familiar with the feeling of hopelessness,” said Theresa Nguyen, Chief Program Officer at Mental Health America. “If major depressive disorder progresses to active suicidal ideation, the consequences can be devastating. Patients need treatment options that can help alter the trajectory of an acute depressive episode. Traditional oral antidepressants take weeks or longer to take effect, so medications capable of providing relief within a day have the potential to be life-changing.”

References:

[1] 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. Retrieved August 3, 2020, fromhttps://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

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