FDA Clears Tonix’s Tonmya, First Fibromyalgia Therapy Since 2009

The US Food and Drug Administration approved Tonix Pharmaceuticals’ Tonmya, making it the first new treatment for fibromyalgia in more than 15 years. The once-nightly sublingual formulation of cyclobenzaprine hydrochloride is cleared for use in adult patients with the chronic pain disorder, which affects an estimated 10 million Americans. Regulators based their decision on two pivotal Phase III studies involving nearly 1,000 participants. Over a 14-week period, patients who received Tonmya experienced statistically significant reductions in pain compared with placebo, along with improvements in sleep and overall clinical outcomes. The therapy was generally well tolerated; the most common adverse events included oral numbness, altered taste and drowsiness. Tonix said it plans to launch Tonmya in the United States during the fourth quarter of 2025, positioning the drug as a first-line option in a market that has seen no new entrants for more than a decade.