Tonix Pharmaceuticals announced preliminary data from the Phase 3 AFFIRM study (NCT0243609) evaluating the safety and efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia.
AFFIRM was a 12-week randomized, double-blind, placebo-controlled 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.
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=.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=.038) and Fibromyalgia Impact Questionnaire-Revised (FIQ-R) scores (P<.001).
TNX-102 SL has also shown beneficial effects on improving sleep quality by the daily diary and the PROMIS sleep disturbance scale (P<.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.
Tonix Pharmaceuticals Reports That Sublingual Formulation of Fibromyalgia Drug Reduces Production of a Psychoactive Metabolite, Improving Suitability for Long-Term, Chronic Treatment [press release]. New York, NY. Tonix Pharmaceuticals. Published August 29, 2016. Accessed August 31, 2016.
This article originally appeared on MPR