Tonix Pharmaceuticals has launched Tonmya (cyclobenzaprine), a newly approved oral treatment for adults with fibromyalgia.
Tonmya is the first approved treatment for adults with fibromyalgia in over 15 years. It is a non-opioid analgesic that, when taken at bedtime, significantly reduces fibromyalgia pain and was generally well-tolerated in clinical trials. It is designed for rapid absorption into the bloodstream without being processed by the liver, enhancing both safety and efficacy.
Fibromyalgia is a long-term health condition characterised by chronic pain across the body, often in conjunction with other symptoms such as fatigue, cognitive problems, lack of restorative sleep, headaches and depression. No single treatment has yet been found to be widely effective for fibromyalgia, and many treatments show only limited efficacy.
Clinical trials measured factors such as pain relief, tiredness and quality of sleep among over 1,400 patients. Across phase 3 trials, the drug significantly reduced patients’ daily pain scores compared to placebo at 14 weeks, which was the primary endpoint of the studies. Also compared to placebo, a greater percentage of patients reported a clinically meaningful (>30%) improvement in their pain after three months.
Andrea Chadwick, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System, said: “For years, fibromyalgia patients have struggled with limited treatment options that often fall short. The availability of Tonmya marks a meaningful advancement by targeting neurotransmitters thought to be involved in fibromyalgia.”
Tonix is a US-based company focused on developing vaccines and therapies for diseases of the central nervous system.
“We’re truly excited about this new option for people living with fibromyalgia,” said Sharon Waldrop, founder of the Fibromyalgia Association who has lived experience of the condition. “The availability of TONMYA provides new hope for our community and represents a crucial step forward in fibromyalgia treatment.”