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PTSD

Latest News

FDA Advisory Committee Casts Nearly Unanimous Vote Against Otsuka's PTSD Combination
July 21st 2025
FDA Advisory Committee Casts Nearly Unanimous Vote Against Otsuka's PTSD Combination
By Grace Halsey

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

July 17th 2025

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

By Grace Halsey
Investigational Rapid-Acting PTSD Medication Awarded FDA Breakthrough Therapy Status / image credit ©Feng Yu/stock.adobe.com
July 10th 2025

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

By Grace Halsey
February 3rd 2025

Optimizing PTSD Treatment: The Role of Brexpiprazole and Sertraline in Future Guidelines

By Lori Davis, MD, Sydney Jennings
©MJH Life Sciences
January 29th 2025

PTSD Treatment Advancements: Brexpiprazole-Sertraline Offers New Hope in Phase 3 Trial

By Lori Davis, MD, Sydney Jennings
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FDA to Convene Advisory Committee on Brexpiprazole-Sertraline for Adult PTSD / image credit ©Tada Images - stock.adobe.com

FDA to Convene Advisory Committee on Brexpiprazole-Sertraline for Adult PTSD

ByPatient Care Editorial Staff
January 10th 2025

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

sNDA for Brexpiprazole/Sertraline Combination for PTSD Submitted for FDA Review / image credit  FDA logo: ©Araki Illustrations/stock.adobe.com

sNDA for Brexpiprazole/Sertraline Combination for PTSD Submitted for FDA Review

ByHeidi Anne Duerr, MPH
May 3rd 2024

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.

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