FDA OKs Esketamine Nasal Spray Monotherapy for Depression

The US Food and Drug Administration (FDA) has approved a supplemental new drug application allowing esketamine nasal spray (Spravato; Johnson & Johnson) to be used as a standalone treatment in adults with major depressive disorder who have not responded adequately to at least two oral antidepressants. 

The FDA first approved esketamine nasal spray for treatment-resistant depression in combination with an oral antidepressant, as reported by Medscape Medical News.

The expanded indication as monotherapy is supported by a double-blind, randomized placebo-controlled trial that demonstrated “rapid and superior” improvement in Montgomery-Asberg Depression Rating Scale (MADRS) scores with esketamine nasal spray monotherapy compared with placebo, the company said in a news release. 

At 4 weeks, 22.5% of patients using esketamine nasal spray achieved remission (MADRS total score ≤ 12) compared with only 7.6% of patients using placebo. 

“For more than 6 years, I’ve seen firsthand the real-world impact Spravato can have on patients’ lives,” Gregory Mattingly, MD, with St. Charles Psychiatric Associates and Midwest Research Group, St. Charles, Missouri, said in the 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,” Mattingly said. 

The safety profile of esketamine nasal spray as a standalone treatment mirrors that when used with oral antidepressant medication, the company said. 

The potential risk for serious adverse outcomes associated with the drug, including sedation and dissociation and the potential for abuse and misuse, means it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy.