FDA Awards Breakthrough Status to Post Traumatic Stress Drug
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.