Publication of results from phase III RELIEF trial of TNX 102 SL for the management of fibromyalgia

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.

“There continues to be a pressing need for novel, safe and more tolerable drugs to treat patients with fibromyalgia, a debilitating chronic disease that afflicts an estimated 6 to 12 million adults in the United States, with symptoms including multisite pain and disturbed sleep,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Current fibromyalgia therapies have limited efficacy in alleviating symptoms of sleep disturbance and fatigue. These Phase 3 RELIEF data suggest that treatment with TNX 102 SL may improve sleep quality and fatigue in patients with fibromyalgia, in addition to reducing pain.”

The paper, titled, “Efficacy and Safety of TNX 102 SL (Sublingual Cyclobenzaprine) 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 III RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. Also, in an exploratory analysis, when the primary endpoint was analyzed as a greater than 30% pain responder analysis, there was a higher rate of responders to TNX 102 SL (47%) than to placebo (35%; p=0.006). 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 (17.7% and 16.5%, respectively). 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 III study (RESILIENT). Topline results are expected in the fourth quarter of this year.

See-Efficacy and Safety of TNX 102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results From the Randomized, Placebo-Controlled RELIEF Trial"-Seth Lederman MD, Lesley M. Arnold MD, Ben Vaughn MS,et al. Arthritis Care & Research First published: 11 May 2023.