FDA Approves the First and Only Monotherapy for Treatment-Resistant Depression

Johnson & Johnson recently announced the US Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO (esketamine) CIII nasal spray for the treatment of adults living with major depressive disorder (MDD) who have not responded to at least two oral antidepressants.

MDD stands as one of the most common psychiatric disorders, affecting about 21 million adults in the US. Approximately one-third of adults fail to respond to oral antidepressants alone, which has a markedly negative impact on quality of life. Overall, MDD incurs an economic burden, with nearly half of it attributable to treatment-resistant depression (TRD).

This FDA approval was granted following priority review and is backed by the positive results from the randomized, double-blind, multicenter, placebo-controlled study which demonstrated that SPRAVATO  alone yielded a rapid and superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score versus placebo.

The findings of a post-hoc analysis of SPRAVATO demonstrated statistically meaningful improvements across all 10 MADRS items at 28 days. At week four, the findings showed that 7.6% of patients taking placebo and 22.5% of patients taking SPRAVATO achieved remission (MADRS total score ≤12). The therapy’s safety profile as a standalone treatment was consistent with the existing body of clinical and real-world data when used in conjunction with an oral antidepressant, with no new safety concerns, the researchers noted.

“For more than six years, I’ve seen firsthand the real-world impact SPRAVATO^® can have on patients’ lives,” said Gregory Mattingly, MD, President of theMidwest Research Group and Founding Partner of St. Charles Psychiatric Associates, via a press release. “Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs, so patients can experience the efficacy of SPRAVATO^® in as little as 24 hours, through day 28, without the need for a daily oral antidepressant.”