Saturday, August 24, 2019

Saturday, August 24, 2019

FDA approves new doctor-certified antidepressant nasal spray


The USDA recently approved Spravato (esketamine), a new antidepressant nasal spray. The spray, in conjunction with an oral antidepressant for the treatment of adult depression, will be available for those who have tried other antidepressant medications with no positive benefits.

Due to the high risk of adverse outcomes due to sedation and dissociation from Spravato administration, the drug is only available through a restricted distribution system under the Risk Evaluation and Mitigation Strategy.

“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,” said Tiffany Farchione, acting director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research. “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.”

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US Food and Drug Administration

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