The US Food and Drug Administration (FDA) has expanded approval for Johnson & Johnson’s Spravato, a nasal spray derived from ketamine, to allow its standalone use as a treatment for patients with severe depression. The company announced the news on Tuesday.
Spravato was initially approved in 2019 as an adjunct therapy for depressive episodes and suicidal thoughts. A new study showed that treating patients with the therapy resulted in rapid and superior improvement in severity of depressive episodes compared to placebo. Over 20% of patients who took Spravato achieved remission, according to J&J.
The FDA’s approval is based on a third of US adults not responding to oral antidepressants alone, highlighting the need for additional treatment options. Spravato works by targeting glutamate, a neurotransmitter involved in various functions.
However, the exact mechanism behind Spravato’s antidepressant effect remains unknown. Due to potential misuse risks, Spravato is only available through a restricted program. The approval marks an expansion of its previous uses and gives healthcare providers more flexibility to tailor treatment plans for individual patients.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-jjs-ketamine-based-therapy-treat-depression-2025-01-21