NEW YORK, May 30, 2017 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, presented an oral pipeline presentation on May 30, 2017 entitled "Low-Dose Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) for the Treatment of Military-Related PTSD: Retrospective Analyses of the Mediators and Moderators of Treatment Response" at the 2017 American Society of Clinical Psychopharmacology Annual Meeting in Miami Beach. The presentation can be found on the Scientific Presentations page on Tonix's website. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication. The U.S. Food and Drug Administration (FDA) has recently granted Breakthrough Therapy designation to TNX-102 SL for posttraumatic stress disorder (PTSD).

A mediator variable specifies how a particular effect or relationship between two other variables occurs. Sleep quality was a potential mediator of treatment response because improvements in sleep quality measured at week 4 by the PROMIS Sleep Disturbance scale in patients receiving TNX-102 SL 5.6 mg correlated with reduction in PTSD severity measured by change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score at week 12. Baseline PTSD severity threshold was a potential moderator of treatment response. A retrospective analysis of the Phase 2 AtEase* data indicated a study entry CAPS-5 severity score of =33 is more aligned with the entry criteria of previous PTSD pharmacotherapy registration trials using prior CAPS versions. In the AtEase baseline CAPS-5 =33 subgroup, the effect size of TNX-102 SL 5.6 mg is approximately 0.5 on total CAPS-5 and also approximately 0.5 on cluster B (intrusion) and cluster E (arousal and reactivity) scores. The effect of TNX-102 SL was studied on remission, which was defined by CAPS-5 < 11 at week 12, and sustained remission, which was CAPS-5 < 11 at both weeks 8 and 12. TNX-102 SL 5.6 mg showed a statistically significant increase in sustained remission relative to placebo. TNX-102 SL was well-tolerated with a high completion rate in AtEase. Non-dose related tongue numbness was commonly reported in participants receiving TNX-102 SL 2.8 mg or 5.6 mg, which was generally transient and never rated as severe. There were no adverse event-related discontinuations in the TNX-102 SL 5.6 mg group. No clinically significant changes in weight or vital signs over the 12 weeks of study were observed.

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