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Esketamine (Spravato) can now be used to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
FDA approved a new indication for the controversial esketamine (Spravato CIII, Janssen) nasal spray for depression.
While Spravato is already approved to treat depression, the agency okayed a supplemental new drug application for Spravato, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
“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.
Janssen garnered criticism after Spravato’s original approval last year, because 3 patients who received the drug died by committing suicide during the clinical trials, “raising red flags Janssen and the FDA dismissed,” Kaiser Health News reported.
The wholesale acquisition cost (WAC) for Spravato was also controversial at the time. It was reported to be between $2,360 and $3,540 per course of treatment.
Janssen also presented “modest” clinical trial data and no information about the safety of Spravato for long-term use beyond 60 weeks to FDA, according to Kaiser Health News.
However, Spravato 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.
“Janssen is working to responsibly educate and certify treatment centers in accordance with the REMS so healthcare providers can offer Spravato to appropriate patients,” the pharma maker said.
The effectiveness of Spravato in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated, Janssen added.
The sNDA approval is based on two identical Phase 3 clinical trials in which Spravato 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.
Spravato 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 to a reduction of 12.0 and 12.2 points in the placebo plus comprehensive standard of care group.