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 three studies, Tonmya was generally well tolerated, with the most common adverse effects including oral numbness, discomfort, abnormal taste and drowsiness.
Tonmya is expected to become commercially available in the US during the fourth quarter of 2025.
