The US Food and Drug Administration (FDA) has approved esketamine nasal spray (Spravato, Janssen Pharmaceuticals) for 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 in the FDA's Center for Drug Evaluation and Research, said in an FDA release announcing the drug's approval.
"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," Farchione added.
The potential risk for serious adverse outcomes associated with the drug, including sedation and dissociation and the potential for abuse and misuse, means it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy.
The patient self-administers the esketamine nasal spray under the supervision of a healthcare provider in a certified doctor's office or clinic. Patients are not permitted to take the drug home.
In addition, patients must be monitored by a healthcare provider for at least 2 hours after the drug is administered. During and after each use of the nasal spray device, the healthcare provider is required to check the patient and determine when the patient is ready to leave.
Prescribers and patients are also required to sign a Patient Enrollment Form that states that the patient understands they should make arrangements to safely leave the healthcare setting to get home. In addition, patients are cautioned that they should not drive or use heavy machinery on the day they receive the drug.
The FDA's decision comes on the heels of last month's 14-to-2 vote (1 abstention) from two FDA advisory panels — the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee — recommending the drug's approval.
As reported by Medscape Medical News at the time, several panel members noted that the drug may be a game changer for patients suffering from severe depression.
The FDA's approval of the drug is based on safety and efficacy data from five phase 3 studies.
Results from both a short-term phase 3 study and a long-term phase 3 study showed that esketamine nasal spray in combination with a newly initiated oral antidepressant "provided statistically significant, clinically meaningful, rapid and sustained improvement of depressive symptoms in this difficult-to-treat population," the company said in a February 12 news release.
The most common side effects associated with the nasal spray include dissociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity, anxiety, lethargy, increased blood pressure, vomiting, and feeling drunk.
Cite this: FDA Approves Esketamine Nasal Spray for Resistant Depression - Medscape - Mar 05, 2019.