The approval follows a priority review and is based on a clinical trial showing the drug alone led to significant improvement in depressive symptoms compared to placebo, with effects observable as early as 24 hours after being taken, according to a Jan. 21 news release from the drugmaker.
The trial demonstrated that Spravato outperformed the placebo on the Montgomery-Asberg Depression Rating Scale, with 22.5% of patients achieving remission after four weeks, compared to 7.6% in the placebo group.
The drug targets the NMDA receptor in the brain and offers new options for the estimated one-third of depression patients who do not respond to oral antidepressants.
It will be available through a restricted Risk Evaluation and Mitigation Strategy Program due to potential risks of sedation, dissociation and abuse. The drug has been used by over 140,000 patients worldwide so far.
