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“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in the agency’s press release. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”
Because of the risks of sedation, dissociation, and misuse, Spravato is subject to a comprehensive Risk Evaluation and Mitigation Strategy (REMS) program and carries a black-box warning. Patients can take Spravato only under the supervision of a health care professional in the office of a certified physician and must be monitored by a health care professional for at least two hours after the administration of the drug. The patient must remain on site until the health care professional determines it is safe for the patient to leave. In addition to the medication’s serious side effects, the black-box warning notes the risk of abuse and misuse.
In a Phase 3 clinical trial of adults with treatment-resistant depression, 223 patients were randomized to receive twice weekly doses of Spravato or placebo. All participants also took an oral antidepressant. Those who took the active nasal spray experienced greater improvement in their depression symptoms at four weeks compared with those who took placebo nasal spray. In a longer study, those who continued taking Spravato along with an oral antidepressant were 51% less likely to relapse than those who took a placebo and an oral antidepressant. Two other short-term trials did not meet prespecified statistical tests for demonstrating effectiveness.
Janssen, maker of Spravato, said in a statement that the company is “working quickly to educate and certify treatment centers in accordance with the REMS.” The company plans to post information about certified treatment centers later this month at https://www.spravato.com.
For related information, see the American Journal of Psychiatry study “Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study.”
