Tonix Pharmaceuticals announces publication of Phase 3 RELIEF trial results

Tonix Pharmaceuticals Holding announced that previously disclosed results from the Phase 3 RELIEF study of TNX-102 SL for the management of fibromyalgia have been published in the peer-reviewed journal Arthritis Care & Research, an official journal of the American College of Rheumatology. In RELIEF, treatment with TNX-102 SL was associated with significant reductions in daily pain and was generally safe and well tolerated in patients with fibromyalgia. Secondary results also suggest that treatment with TNX-102 SL can improve sleep and reduce fatigue, which together with pain are recognized as core fibromyalgia symptoms. TNX-102 SL is a novel, non-opioid, centrally-acting analgesic, intended to be taken once daily at bedtime. The paper, titled, “Efficacy and Safety of TNX-102 SL for the Treatment of Fibromyalgia: Results From the Randomized, Placebo Controlled RELIEF Trial,” includes data demonstrating that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo in participants with fibromyalgia. Also, in an exploratory analysis, when the primary endpoint was analyzed as a greater than or equal to30% pain responder analysis, there was a higher rate of responders to TNX-102 SL than to placebo. TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue and fibromyalgia-specific global symptomatic and functional recovery. Early discontinuation rates were similar for TNX-102 SL and placebo. In addition, TNX-102 SL was well tolerated with the most common adverse event from active treatment being oral numbness or hypoaesthesia, an administration site reaction that is typically transient, was never rated as severe, and lead to only one discontinuation. Tonix is currently enrolling in a potentially confirmatory, registration-enabling Phase 3 study. Topline results are expected in the fourth quarter of this year.