The FDA announced that it has approved Janssen’s NDA for Spravato esketamine nasal spray for the treatment of treatment-resistant depression. Spravato is to be used with an oral antidepressant and distribution will restricted under a risk evaluation and mitigation strategy (REMS).
The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee recommended approval of the nasal spray when they met on February 12, 2019. Janssen submitted the NDA in September 2018.
The label for Spravato will include a boxed warning about the risks of sedation, dissociation, misuse, and suicidal thoughts and actions, and patients using Spravato will have to be monitored for a minimum of 2 hours after dosing by a health care professional. Under the REMs, both the patient and prescriber will have to sign a form acknowledging that the patient will need to avoid driving or operating heavy machinery for the remainder of the day.
Janssen Research & Development Global Head Mathai Mammen said, “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. This unique and innovative medicine is a testament to Janssen’s heritage of advancing solutions in neuroscience to heal minds and improve health outcomes.”
The acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, Tiffany Farchione, commented, “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition. 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 safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”
The company says that it “is working quickly to educate and certify treatment centers in accordance with the REMS so healthcare providers can offer Spravato to appropriate patients.”
Read the FDA press release.
Read the Janssen press release.
