Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents
Shots:
- The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025
- Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by PANSS total score
- Rxulti modulates serotonin & dopamine systems, combining partial agonist activity at 5-HT1A & D2 receptors with antagonist activity at 5-HT2A receptors. It also antagonizes noradrenergic α1B/2C receptors within the sub-nanomolar Ki range
Ref: Bussineswire | Image: Otsuka and Lundbeck
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