The FDA has approved esketamine nasal spray, combined with an oral antidepressant, for the treatment of adults with treatment-resistant depression, according to a press release.
Due to safety concerns, esketamine nasal spray (Spravato, Janssen Pharmaceuticals) will only be available through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS) and must be administered in a certified medical office, according to the release.
This is the first FDA approval of esketamine for any use. This approval follows recommendations from the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee and positive data from multiple studies supporting esketamine nasal spray for patients with treatment-resistant depression.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," Tiffany Farchione, MD, acting director of the division of psychiatry products at the FDA's Center for Drug Evaluation and Research, said in the 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.”
Labeling for esketamine nasal spray contains a boxed warning on the risk for sedation and dissociation; abuse and misuse; and suicidal thoughts and behaviors after administration. Patients must be monitored by a health care provider for at least 2 hours after receiving a dose, according to the release. Under REMS, prescribers and patients must sign a Patient Enrollment Form, and the drug must be dispensed with a patient Medication Guide outlining uses and risks.
Patients will self-administer esketamine nasal spray under in a certified clinic or doctor’s office under provider supervision, and the health care providers will determine when patients can leave after each use, according to the release.
“The approval of esketamine as a new medication for treatment-resistant depression is welcome news for people and their families who are impacted by depression,” Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation, said in a press release. “We are pleased that the Brain & Behavior Research Foundation funding of both early research and ongoing studies on rapid-acting antidepressants has helped lead to this development of a new medication for treatment-resistant depression.”