FDA Awards Breakthrough Status to Post Traumatic Stress Drug

Article

Drug candidate can treat individuals who have PTSD associated with their military service.

The FDA has granted breakthrough therapy designation to a drug candidate for post-traumatic stress disorder (PTSD).

Cyclobenzaprine HCl sublingual tablets, known as TNX-102 SL, is made by Tonix Pharmaceuticals. According to the drug company, the designation was granted on the basis of the phase 2 study AtEase, which enrolled subjects who have PTSD associated with their military service. The trial was a 12-week, randomized controlled study.

A phase 3 study will begin in the first quarter of 2017, the company said.

The evidence of the phase 2 trial showed the drug, "may demonstrate substantial improvement over existing therapies one or more clinically significant endpoints," the company said in a news release.

An estimated 8 million people in the United States have episodes of PTSD, the company said.

Current treatments are generally with selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

Tonix Pharmaceuticals Holding Company is based in Manhattan.

Related Videos
Aimee Keegan, PharmD, BCOP, a clinical pharmacist
Aimee Keegan, PharmD, BCOP, a clinical pharmacist
Video 2 - "Achieving Post-Discharge Success: Goals in Hepatic Encephalopathy Care"
Video 1 - "Identifying and Screening for Hepatic Encephalopathy Risk Factors"
© 2024 MJH Life Sciences

All rights reserved.