FDA announcements and safety warning updates

FDA Approves Johnson & Johnson's Spravato Nasal Spray as First and Only Standalone Treatment for 21 Million US Adults with Depression

Jan 21, 2025, 06:44 PM

The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first and only monotherapy for adults with treatment-resistant major depressive disorder (MDD). This approval allows the nasal spray to be used alone, marking a significant expansion from its previous approval, which required patients to be on other antidepressant medications. The FDA's decision is expected to benefit the estimated 21 million adults in the U.S. living with MDD who have not responded adequately to at least two oral antidepressants. Spravato has been administered to over 140,000 patients globally and has nearly six years of real-world data supporting its efficacy.