PTSD

The FDA advisory committee overwhelmingly voted against Otsuka's PTSD treatment, citing insufficient evidence from clinical trials for approval.

FDA's Psychopharmacologic Drugs Advisory Committee will evaluate the novel brexpiprazole/sertraline combination, weighing efficacy against existing therapies amid mixed trial results.

TSND-201, a rapid-acting neuroplastogen, demonstrated statistically significant symptom improvement by day 10, which was durable throughout the study until Day 64.

Brexpiprazole and sertraline showed promise for PTSD treatment in a recent study. Lead author, Lori Davis, MD, discusses clinical findings, treatment guidelines, and future research directions.

Data showed that brexpiprazole plus sertraline significantly improved PTSD symptoms vs sertraline alone. Lead author, Lori Davis, MD, discusses more.

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.