Tonix Pharmaceuticals (NASDAQ:TNXP) saw its shares climb 8% on Monday after the company announced that TONMYA, its newly approved treatment for fibromyalgia, has officially launched in the U.S. and is now available by prescription.
TONMYA (cyclobenzaprine HCl sublingual tablets) is a once-nightly, non-opioid pain therapy intended for adults diagnosed with fibromyalgia. The FDA granted approval for the medication on August 15, 2025, marking the first new fibromyalgia therapy to reach the U.S. market in more than 15 years.
Approval was supported by results from two Phase 3 studies involving nearly 1,000 participants. In these trials, TONMYA achieved statistically significant reductions in daily pain levels at 14 weeks versus placebo. A larger share of treated patients also experienced clinically meaningful pain improvement after three months of therapy.
“The availability of TONMYA is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain,” said Seth Lederman, CEO of Tonix Pharmaceuticals.
Safety data from the clinical program indicated that the most common side effects included oral hypoesthesia, oral discomfort, altered taste, and somnolence. Across three late-stage trials enrolling more than 1,400 patients, TONMYA was generally well tolerated.
The most recent Phase 3 findings—published in Pain Medicine—included detailed analyses of both primary pain endpoints and secondary measures such as overall symptom burden, functional outcomes, sleep quality, and fatigue.