Fabre-Kramer Pharmaceuticals’ Exxua Receives the US FDA’s Approval for the Treatment of Major Depressive Disorder in Adults
Shots:
- The US FDA has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with MDD. The therapy is expected to be available in pharmacies in early 2024 & is also being developed for other psychiatric disorders
- The efficacy of Exxua was based on two 8wk. PBO-controlled studies in a ratio (1:1) in adults aged 18-69yrs. The results showed that patients treated with Exxua (selective 5HT1a receptor agonist) achieved a greater improvement in the HAMD-17 total score at 8wk.
- Acc. to adverse event data collected in clinical trials, Exxua were found to be comparable to PBO & showed an overall acceptable safety profile with no significant adverse effect on weight, blood pressure, heart rate, or liver function
Ref: PR Newswire | Image: Fabre-Kramer Pharmaceuticals
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