The U.S. Food and Drug Administration has approved Tonix Pharmaceuticals’ Tonmya, a once-daily sublingual formulation of cyclobenzaprine, for the treatment of fibromyalgia in adults. The decision marks the first new FDA-authorized therapy for the chronic pain disorder in more than 15 years and provides patients with a non-opioid option designed for bedtime dosing and rapid absorption. Approval was based on two double-blind, placebo-controlled Phase 3 trials that enrolled roughly 1,000 participants. At 14 weeks, Tonmya significantly reduced daily pain scores and achieved clinically meaningful pain relief in a larger share of patients than placebo. The treatment was generally well tolerated; the most common adverse events included oral numbness, abnormal taste and somnolence. Tonix said it expects to make Tonmya commercially available in the United States during the fourth quarter of 2025 and will discuss launch plans on a webcast scheduled for 18 August.