Wedoany.com Report-Dec.1, Tonix Pharmaceuticals has commercially launched Tonmya (cyclobenzaprine HCl sublingual tablets, 2.8 mg) in the United States, following FDA approval earlier this year. The product is the first new medication for fibromyalgia to reach the market in over 16 years.

Tonmya is a 5.6 mg bedtime sublingual formulation of cyclobenzaprine, a long-established tricyclic compound, delivered under the tongue. The wholesale acquisition cost is set at $1,860 for a 30-day supply (60 tablets), with a reduced price of $930 for patients aged 65 and older or those with mild hepatic impairment.

Fibromyalgia affects more than 10 million people in the United States, predominantly women (approximately 80 percent of cases), and is characterised by widespread chronic pain, fatigue, sleep disturbance, and cognitive difficulties. Tonmya is designed to be taken once daily at bedtime to alleviate pain and improve sleep quality.

The sublingual route and lower dose compared with traditional oral cyclobenzaprine products minimise first-pass liver metabolism, resulting in a reduced side-effect profile. Approval was supported by two phase 3 clinical trials demonstrating statistically significant pain reduction versus placebo at week 14, along with improvements in sleep quality, fatigue, and overall patient function.

Seth Lederman, chief executive officer of Tonix, stated: "The availability of Tonmya is a momentous day for Tonix, providing […] people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain."

He added: "After more than 15 years without innovation for this disease, we are honoured to bring this new treatment option to patients in partnership with the full fibromyalgia community, including researchers, patients, and investigators."

Tonmya enters a market that includes established therapies such as pregabalin (Lyrica), duloxetine (Cymbalta), and milnacipran (Savella), all now available as lower-cost generic medicines. Tonix will commercialise the product directly in the United States, building on infrastructure established through its earlier acquisition of two migraine treatments, Zembrace SymTouch and Tosymra.

The company is also advancing a 5.6 mg sublingual cyclobenzaprine formulation for another indication and plans to initiate a phase 2 study in major depressive disorder, focusing on sleep disturbance, in mid-2026.

The launch of Tonmya introduces a new non-opioid, centrally acting analgesic option specifically indicated for fibromyalgia, addressing a condition that has seen limited therapeutic advances for more than a decade and a half.