Tonix's PTSD therapy loses breakthrough therapy designation

FDA rescinded breakthrough therapy designation for Tonix's Tonmya cyclobenzaprine (Sublingual TNX-102) to treat military-related posttraumatic stress disorder (PTSD), saying an interim analysis of the Phase III HONOR trial did not sufficiently support the designation.

In August, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) said it would stop the HONOR trial after the sublingual formulation of cyclobenzaprine, a muscle relaxant, showed "inadequate separation" from placebo at an interim analysis of the primary endpoint at week 12 (see "Tonix Stops Phase III of PTSD Candidate on Lack of Separation from Placebo")...