Tonix announces FDA approval of Tonmya for treatment of fibromyalgia

Tonix Pharmaceuticals (TNXP) Holding Corp. announced that the FDA approved Tonmya for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual formulation that is designed for rapid absorption into the bloodstream. Tonmya is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (greater than or equal to30%) improvement in their pain after three months, compared to placebo. Across three Phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well tolerated. Tonmya is expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of this year.