Spravato

FDA Approves J&J's Esketamine Nasal Spray For Hard-To-Treat Depression

Posted on March 07, 2019 by Medtech[y] Staff


On Tuesday, the Food and Drug Administration approved esketamine, the first major depression treatment approved in the U.S. market in decades.

Esketamine, which is developed by Johnson & Johnson's Janssen division, is delivered as a nasal spray and is meant for patients who haven't responded to existing therapies.

The drug will be branded as SPRAVATO (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD).

What to know:

  • SPRAVATO uses the first new mechanism of action in decades to treat major depressive disorder
  • In short- and long-term clinical trials, those who received SPRAVATO and a newly initiated oral antidepressant achieved superior improvement in depression symptoms, and sustained improvement in their symptoms over time compared to adults who received a placebo and an oral antidepressant
  • To support responsible use of the medication while ensuring patient access, SPRAVATO will launch with a controlled distribution model, including a comprehensive Risk Evaluation and Mitigation Strategy

SPRAVATO was studied in a robust Phase 3 clinical trial program with more than 1,700 adults with TRD. In a short-term study, those who took SPRAVATO and an oral antidepressant experienced superior improvement in depression symptoms at four weeks, compared to those who received a placebo and an oral antidepressant.

In a long-term study, patients in stable remission taking SPRAVATO who continued treatment with the medicine were 51 percent less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.

“Depression is a common and potentially debilitating illness that can have profound emotional, functional and economic impact on both those who suffer and their loved ones. The impact of depression is greatest for those who do not benefit from standard treatments,” said Michael E. Thase,* M.D., a professor of psychiatry and director of the Mood and Anxiety Disorders Treatment and Research Program in the Perelman School of Medicine at the University of Pennsylvania, who served as a site principal investigator for the clinical trials. “In Phase 3 clinical trials, we saw this therapy provide sustained improvement to patients with treatment-resistant depression.”

People who are currently struggling with major depressive disorder (MDD) are considered to have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.

Once SPRAVATO is determined as an appropriate treatment option, in accordance with the REMS, the patient will be treated at a certified treatment center that is trained to administer the medicine and address patient needs. SPRAVATO will not be dispensed directly to patients for home use. Instead, SPRAVATO will be self-administered by the patient under the direct observation of a healthcare provider.

“SPRAVATO has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “This unique and innovative medicine is a testament to Janssen’s heritage of advancing solutions in neuroscience to heal minds and improve health outcomes.”