FDA Approves Spravato for Major Depressive Disorder

The FDA has approved Johnson & Johnson's Spravato (esketamine) CIII nasal spray as the first monotherapy for adults with major depressive disorder (MDD) who have not responded adequately to at least two oral antidepressants. This marks a significant development in treating treatment-resistant depression, affecting nearly one-third of the 21 million U.S. adults with MDD. Clinical trials demonstrated rapid and superior efficacy of Spravato, with 22.5% of patients achieving remission by week four compared to 7.6% in the placebo group. The approval follows an FDA Priority Review and supports Spravato's safety profile, aligning with existing data when used alongside oral antidepressants. The treatment is available through a restricted program due to potential risks such as sedation and misuse, aiming to address unmet needs in MDD management. Johnson & Johnson's stock showed a slight increase following the announcement, reflecting market optimism about this new treatment avenue.