Tonix earns FDA approval for Tonmya fibromyalgia therapy

FDA approves Tonix's Tonmya as a non-opioid bedtime analgesic for adults with fibromyalgia, with a U.S. launch planned for late 2025.

Tonix Wins FDA Nod for Tonmya Fibromyalgia Therapy

The U.S. Food and Drug Administration approved Tonix Pharmaceuticals Holding Corp.’s Tonmya (cyclobenzaprine HCl sublingual tablets) for adults with fibromyalgia. Tonmya is a non-opioid, once-daily bedtime analgesic delivered sublingually for rapid absorption. Approval relied on three Phase 3 trials including nearly 1,400 patients, showing a significant reduction in daily pain scores versus placebo at 14 weeks and a higher proportion achieving at least 30% pain relief after three months. Across all three trials, Tonmya was generally well tolerated. The company said Tonmya should be available in the U.S. in the fourth quarter of 2025.

Tonix also disclosed a cash position of 125.3 million, sustaining operations into the third quarter of 2026. In a related note, Axsome Therapeutics faced a regulatory setback after the FDA issued a refusal to file for its own fibromyalgia drug, highlighting ongoing competitive pressures in the space. Over the past six months, Tonix’s stock has surged more than 320%, though Monday trading showed an 8.2% drop to around 47.14 as investors weigh near-term catalysts and execution risk.

The FDA approval adds a new non-opioid option to a field with few recent breakthroughs and gives Tonix a potential growth driver beyond its existing pipeline. The real test will be payer coverage and patient access, which will depend on pricing, formulary decisions, and real-world effectiveness. Tonix now faces a high-wire act: convert clinical promise into broad adoption while managing market expectations and competitive dynamics in fibromyalgia. The decision and the cash runway together create a window for Tonix to execute, but long-term success will hinge on clear value demonstration and efficient commercialization.

Highlights

As Tonix moves from data to delivery, patient access will determine the true impact.