
The adcomm meeting is expected to happen in the first half of 2025, and means the FDA expects to miss the target PDUFA date.

Otsuka and Lundbeck Will Face Scrutiny Over Investigational PTSD Therapy at July 18 FDA AdComm Meeting

Investigational Rapid-Acting PTSD Medication Awarded FDA Breakthrough Therapy Status: Transcend Therapeutics Update

The adcomm meeting is expected to happen in the first half of 2025, and means the FDA expects to miss the target PDUFA date.

The sNDA for the brexpiprazole plus sertraline therapy is based on positive phase 2 and 3 clinical trials showing improvement in PTSD-specific scale scores.