Tonix Pharmaceuticals has announced that its new drug, Tonmya (cyclobenzaprine HCl), has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia. This marks the first time in over 15 years that a new medication for fibromyalgia has reached the market. Tonmya is now available by prescription in pharmacies across the United States.
Tonmya is a non-opioid, once-daily sublingual tablet intended for use at bedtime. The drug works by modulating several receptors, including 5-HT2A, α1, H1, and M1, rather than relying on opioid pathways. According to Tonix Pharmaceuticals, this approach targets both sleep architecture and central pain processing—two key factors in managing fibromyalgia symptoms.
The FDA's decision was based on results from two Phase 3 clinical trials named RELIEF and RESILIENT. These studies included nearly 1,000 adults diagnosed with fibromyalgia. Participants who received Tonmya reported significant reductions in daily pain scores after 14 weeks compared to those who took a placebo. In addition, more patients treated with Tonmya achieved at least a 30% improvement in pain after three months.
Seth Lederman, CEO of Tonix Pharmaceuticals, commented on the development: "The approval of Tonmya reflects the company’s long-term commitment to delivering a therapeutic advance that was overdue." He also noted that this achievement aligns with recent progress in non-opioid pain treatments.
Other advancements have been made in this field as well. For example, Vertex recently gained FDA approval for suzetrigine (Journavx), another non-opioid oral analgesic—the first of its kind approved in decades.
The landscape of chronic pain research is changing. Instead of focusing on a single mechanism, researchers are now exploring multiple scientific approaches and therapeutic targets.
Gregory Sullivan, Chief Medical Officer at Tonix Pharmaceuticals, and Richard Scranton, Vice President of Pain Clinical Development at Vertex, are scheduled to speak at the upcoming Non-Opioid Pain Therapeutics Summit in January. The event will feature discussions on novel therapeutic targets beyond NaV1.8 channels and advances in patient-reported outcomes for pain clinical trials. Leaders from pharmaceutical companies such as Eli Lilly, AbbVie, Novartis, and Merck will also participate in panel discussions during the summit.
The summit will bring together more than 80 experts from discovery through clinical stages who are working to advance non-opioid pain therapies.
