08:38 AM EST, 01/21/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Tuesday that the US Food and Drug Administration has approved Spravato, or esketamine, CIII nasal spray as a standalone treatment for adults with major depressive disorder who showed "inadequate response" to at least two oral antidepressants.

The company said the approval is based on clinical trial data indicating that Spravato as monotherapy improved depressive symptoms as early as 24 hours and met its primary endpoint at 28 days.

The treatment will be available through a restricted program due to potential risks, Johnson & Johnson ( JNJ ) said.