FilingReader Intelligence
FDA panel rejects Otsuka's PTSD drug application
July 21, 2025 at 11:49 PM UTC•By FilingReader AI
The FDA's Psychopharmacologic Drugs Advisory Committee voted 10-1 against adequate data for Otsuka Pharmaceutical's brexpiprazole (Rexulti) in adult PTSD on July 18.
The application was supported by three trials involving 416, 553, and 321 patients. The FDA will consider this outcome during its review of the drug in combination with sertraline.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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