Tonix Pharmaceuticals announced topline results from the Phase 2 AtEase Study, evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of military-related Post-Traumatic Stress Disorder (PTSD).
AtEase is a dose-finding, randomized, placebo-controlled, Phase 2 study designed to evaluate the efficacy of a bedtime sublingual dose of TNX-102 SL 2.8mg or 5.6mg vs. placebo in 231 patients with military-related PTSD. The primary endpoint was the 12-week mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), a standardized structured clinical interview that serves as the gold standard for measuring PTSD symptom severity.
Study results showed that the 2.8mg of TNX-102 SL trended toward the direction of therapeutic effect, however, it failed to reach statistical significance on the primary endpoint (P=0.090). In contrast, treatment with the 5.6mg achieved therapeutic effect as assessed by the CAPS-5 and demonstrated statistical significance (P=0.038), although patients in this arm included half of the patients in the 2.8mg arm. Both TNX-102 SL 2.8mg and 5.6mg doses demonstrated a tolerable safety profile, as evidenced by the high overall completion rate in the treatment groups compared to the placebo group (79%, 84%, 73%, respectively).
Detailed data from the AtEase Study will be presented at the American Society of Clinical Psychopharmacology Annual Meeting on May 31, 2016.
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.
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