Tonix Pharmaceuticals announced preliminary data from the Phase 3 AFFIRM study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia.

AFFIRM was a 12-week randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of TNX-102 SL 2.8mg at bedtime in 519 patients with fibromyalgia. The primary efficacy endpoint was the proportion of patients who reported a ≥30% reduction in pain from baseline to the end of the 12-week treatment period based on the pre-specified primary analysis. 

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Results from the study showed that treatment with TNX-102 SL failed to achieve statistical significance in the primary efficacy endpoint of ≥30% reduction in pain from baseline (P=0.095). However, statistical significance was achieved in secondary endpoints that assess global improvement and a range of fibromyalgia symptoms and function, including Patient Global Impression of Change (PGIC; P=0.038) and Fibromyalgia Impact Questionnaire-Revised (FIQ-R) scores (P<0.001). TNX-102 SL has also shown beneficial effects on improving sleep quality by the daily diary and the PROMIS sleep disturbance scale (P<0.001 for both).

TNX-102 SL was found to be generally well-tolerated, with similar adverse events (AEs) from those seen in other TNX-102 SL clinical trials. The most frequent AEs include transient tongue numbness, fatigue, and somnolence.

Tonix intends to discontinue the clinical development program of TNX-102 SL for the fibromyalgia indication in order to focus its advancement for the breakthrough Posttraumatic Stress Disorder (PTSD) program.

TNX-102 SL, an investigational, sublingual formulation of cyclobenzaprine, has antagonistic activities at the serotonin-2A, alpha-1 adrenergic, and histamine H1 receptors.  

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