FDA Pulls Fast-Track Designation for PTSD Treatment

March 21, 2019

The FDA revoked its breakthrough therapy designation for Tonix’s posttraumatic stress disorder drug Tonmya (cyclobenzaprine HCl sublingual tablets), citing disappointing interim data from a clinical trial.

The agency said it withdrew the designation because data from the sponsor’s HONOR study didn’t support continued fast-tracking. The study, which tested the drug in military-related PTSD, was halted last July because of “inadequate separation from placebo on the primary endpoint at week 12,” the drugmaker said.

Tonix said that the agency’s decision to void its breakthrough designation would not interrupt the company’s drug application plan. The company is on track to begin its Phase 3 RECOVERY trial in civilian and military-related PTSD, he said.

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