For the first time in years, a new medication will be available for people with depression.
The U.S. Food and Drug Administration approved esketamine, a nasal spray designed to treat severe forms of depression that are unresponsive to at least two other antidepressant medications. The drug will be sold under the brand name Spravato.
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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 Dr. Tiffany Farchione, the acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.
Treatment-resistant depression affects about one-third of the estimated 16.2 million American adults who have suffered a major depressive episode. They have a heightened risk of suicide.
The nasal spray is only available through a restricted distribution system, because of the risk of sedation and dissociation. The drug must be administered in a certified medical setting and the spray cannot be taken home. Depending on the patient, the Spravato should be administered either weekly or every other week.
After administration, patients must be monitored by a health care provider for at least two hours. Patients must also make transportation arrangements because they are not to drive or use heavy machinery for the remainder of the day.
Manufactured by Janssen Pharmaceuticals, Spravato will be priced similarly to other specialty mental health drugs – about $590 to $885 per treatment session, according to CNN. Those prices may vary based on dosage, mandatory discounts and negotiated rebates.
The drug will include a boxed warning noting risks for sedation, difficulty with attention, dissociation, suicidal thoughts, and abuse and misuse.
The most common side effects observed during clinical trials included disassociation, dizziness, nausea, sedation, vertigo, hypoesthesia (reduced sense of touch or sensation), anxiety, lethargy, increased blood pressure, vomiting and feeling inebriated.
The drug has a similar chemical makeup to ketamine, a painkiller with hallucinogenic effects.
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