Posted by Michael Wonder on 06 Mar 2019
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic
5 March 2019 - The U.S. FDA today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).
Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy.
The efficacy of Spravato was evaluated in three short-term (four-week) clinical trials and one longer-term maintenance-of-effect trial. In the three short-term studies, patients were randomised to receive Spravato or a placebo nasal spray.
