FDA Clears Tonix’ INDA for PTSD Drug

Tonix Pharmaceuticals announced that the FDA has cleared its investigational new drug application to develop the post-traumatic stress disorder drug, TNX-102 SL, an exclusive under-the-tongue formulation of cyclobenzaprine HCl.

The company will now be able to move forward with its planned U.S. Phase II clinical trial designed to assess the safety and efficacy of TNX-102 SL in patients who suffer from the traumatic event-triggered mental illness. The study will occur in the third quarter of this year, the New York City-based company said.

The randomized, double-blind, placebo-controlled Phase II clinical trial (TNX-CY-P201) will evaluate the safety and efficacy of two doses of TNX-102 SL versus placebo. Doses will be administered once daily at bedtime, the company said, adding that efficacy analysis of the trial will compare differences in mean scores on the Clinician-Administered PTSD Scale.

Tonix said it expects to enroll 220 patients with military-related PTSD in the 12-week trial to be carried out at about 30 sites in the US.

An estimated eight million adults suffer from PTSD, and face unmet needs and limited treatment options, the company said. — Kellen Owings

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