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Phase III RECOVERY study of TNX 102 SL fails to meet significance in PTSD.- Tonix Pharma

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Published:22nd Dec 2020
Tonix Pharmaceuticals announced topline results from its Phase III RECOVERY study of TNX 102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of civilian and military-related posttraumatic stress disorder (PTSD). The RECOVERY study did not achieve statistical significance in the prespecified primary efficacy endpoint of change from baseline to Week 12 in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between TNX 102 SL and placebo (p=0.343). In the primary analysis, TNX 102 SL subjects achieved a 20.7 unit reduction in CAPS-5 versus 18.5 units for placebo. TNX 102 SL separated from placebo in the first key secondary endpoint, Clinical Global Impression – Severity (CGI-S) scale (p=0.024) and in the Patient Global Impression of Change (PGIC), (p=0.007). TNX 102 SL also trended for improvement on the PROMIS Sleep Disturbance scale (p=0.055), consistent with the proposed mechanism of targeting the PTSD sleep disturbance. Among completers, there was a 58% observed mean reduction in symptoms in the active group compared to 49% in the placebo group, as measured by CAPS-5 total. TNX 102 SL is generally well tolerated and no new safety signals were observed.
Condition: Post Traumatic Stress Disorder
Type: drug

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