FDA rejects Otsuka’s brexpiprazole for PTSD treatment

Otsuka Pharmaceutical, a wholly-owned subsidiary of Otsuka Holdings, announced that the U.S. FDA issued a Complete Response Letter (CRL) regarding its supplemental New Drug Application (sNDA) for the antipsychotic drug Rexulti (brexpiprazole). The application sought approval for the additional indication of post-traumatic stress disorder (PTSD) in adults, but the FDA stated the submitted data was insufficient.

This FDA decision followed a July 18 Psychopharmacologic Drugs Advisory Committee (PDAC) meeting, where a vote on whether "the applicants (Otsuka Pharmaceutical and Lundbeck) have provided sufficient data for the additional indication of PTSD in adults" resulted in a negative view, with 1 in favor and 10 against.

Despite the rejection, Otsuka Holdings stated that there are no changes to the consolidated financial forecast for the fiscal year ending December 2025, which was publicly announced in July 2025.