The Food and Drug Administration (FDA) has approved Spravato (
The approval was based on data from 3 short-term (4-week) studies and 1 long-term maintenance-of-effect trial assessing the safety and efficacy of esketamine, a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist; patients in these studies had a history of inadequate response to least 2 prior antidepressants and generally had more severe symptoms than those who participated in antidepressant studies for previously approved drugs.
Results from 2 of these phase 3 studies (1 short-term, 1 long-term), which primarily provided the evidence to support effectiveness, showed that treatment with esketamine nasal spray plus a newly initiated oral antidepressant was associated with a statistically significant, clinically meaningful, rapid, and sustained improvement of depressive symptoms vs placebo nasal spray plus a newly initiated oral antidepressant.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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.”
Spravato carries a Boxed Warning describing the potential for sedation, dissociation, abuse/misuse, and suicidal thoughts and behaviors that may result from use of this product. Because of these risks, Spravato is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).
According to the Spravato REMS, the treatment can only be dispensed by certified healthcare settings and only to patients enrolled in the program. In addition, Spravato must be administered under the direct observation of a healthcare provider; the patient self-administers the medication after receiving instructions from the provider. Patients should be monitored for at least 2 hours after administration until it is determined that they are clinically stable and are ready to leave the healthcare setting.
Each Spravato nasal spray device delivers 2 sprays containing a total of esketamine 28mg; the product is classified as a Schedule III controlled substance.
For more information call (800) 526-7736 or visit Spravato.com.