FDA Approves Spravato Nasal Spray for Treatment-Resistant Depression
WEDNESDAY, Jan. 22, 2025 -- The U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants, according to a news release issued by Johnson & Johnson.
Spravato is the first and only approved monotherapy for adults with refractory major depressive disorder. Approval of Spravato, granted following FDA priority review, was based on the results of a randomized, double-blind, multicenter, placebo-controlled trial. On day 28 of the trial, patients taking Spravato exhibited numerical improvements for all 10 items on the Montgomery-Asberg Depression Rating Scale (MADRS). After four weeks, 22.5 percent of patients taking Spravato achieved remission (score ≤12 on MADRS) compared with 7.6 percent of patients taking placebo.
Spravato nasal spray is administered by the patient under the supervision of a health care provider in a health care setting. Spravato targets the neurotransmitter glutamate; however, the mechanism by which esketamine exerts its antidepressant effect is unknown. In an effort to ensure the safe and appropriate use of Spravato, the medication is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy Program. This is due to the risks for serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse.
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, health care providers have had few options to offer patients much-needed symptom improvement," Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine, said in a statement. "Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days -- without the need for daily oral antidepressants."
Approval of Spravato was granted to Johnson & Johnson.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.
Read this next
OpenAI Launches Teen-Safe ChatGPT With Parental Controls
THURSDAY, Sept. 18, 2025 — Teenagers chatting with ChatGPT will soon see a very different version of the tool — one built with stricter ways to keep them safe online...
Psilocybin For Depression Effective Up To Five Years After Treatment
MONDAY, Sept. 15, 2025 — The benefits of psilocybin treatment for depression might last as long as five years for some, a new study says. Two-thirds of participants in an...
Precise Brain Stimulation May Offer Faster Relief for Depression
FRIDAY, Sept. 12, 2024 — A new type of noninvasive brain stimulation may help people with moderate to severe depression feel better faster than standard treatments...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.