Tonix announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD)

The designation was supported by preliminary data from the 12-week randomized, double-blind, placebo-controlled Phase 2 AtEase study in military-related PTSD that favored treatment with TNX-102 SL over currently available treatments. 

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TNX-102 SL, a sublingual formulation of cyclobenzaprine, is a serotonin-2A, alpha-1 adrenergic, and histamine H1 antagonist under development for PTSD to provide broad spectrum improvement by targeting sleep and the stress response.

The Phase 3 HONOR study is anticipated to begin enrollment in the first quarter of 2017 pending an FDA agreement on the study’s design and interim analysis plan.

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