FDA approves first new fibromyalgia therapy in over 15 years
Ella Day | August 18, 2025 | News story | Medical Communications, Research and Development | Pain, Tonix Pharmaceutical, US Food and Drug Administration, chronic pain, clinical trial, fibromyalgia
The US Food and Drug Administration (FDA) has approved Tonix Pharmaceutical’s Tonmya (cyclobenzaprine hydrochloric acid) for the treatment of fibromyalgia in adults, making it the first new therapy authorised for the condition in more than 15 years.
Fibromyalgia is a chronic pain disorder that affects an estimated ten million adults in the US, the majority of whom are women. Symptoms include widespread pain, fatigue, sleep disturbance and cognitive difficulties.
Approval of Tonmya was supported by two pivotal phase 3 trials involving nearly 1,000 patients, which demonstrated statistically significant reductions in fibromyalgia-related pain compared with placebo after 14 weeks of treatment. Across three phase 3 studies, Tonmya was generally well tolerated, with the most common adverse effects including oral numbness, discomfort, abnormal taste and drowsiness.
Seth Lederman, CEO of Tonix, said: “The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the US suffering from the debilitating pain this condition causes.”
Patient advocates also welcomed the decision. Sharon Waldrop, founder of the Fibromyalgia Association, commented: “For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”
Tonmya is expected to become commercially available in the US during the fourth quarter of 2025.
Ella Day
18/8/25
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