Tonix Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Tonmya (cyclobenzaprine HCl sublingual tablets) to treat fibromyalgia in adults.

Fibromyalgia is a chronic pain condition that affects approximately ten million adults in the US, with 80% of those affected being women.

Tonmya is a non-opioid analgesic intended for once-daily use at bedtime. It features a sublingual formulation that allows for rapid absorption into the bloodstream.

Investigated as TNX-102 SL, Tonmya is a patented formulation of cyclobenzaprine hydrochloride that facilitates rapid absorption and reduces the formation of a long-acting metabolite.

The therapy acts as a multifunctional agent, targeting various receptors in the body. The US Patent and Trademark Office has granted multiple patents, ensuring market exclusivity until 2034, with potential extensions until 2044 for related applications.

Tonix Pharmaceuticals CEO Seth Lederman stated: “The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the US suffering from the debilitating pain this condition causes.

“At Tonix, we recognised the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition (COPC), that has gone without innovation for many years.”

The approval was based on data from two Phase III clinical trials involving 1,000 participants, which demonstrated that Tonmya significantly reduced daily pain scores compared to a placebo over 14 weeks.

Tonmya has been evaluated in three Phase III clinical trials with more than 1,400 patients.

The RELIEF and RESILIENT trials were designed as double-blind, placebo-controlled studies to assess safety and efficacy for fibromyalgia treatment.

The RELIEF trial enrolled 503 adults, while the RESILIENT trial included 457 participants, both conducted across multiple sites in the US.

Tonmya will be accessible to adults in the US with fibromyalgia by the fourth quarter of 2025

In 2023, Tonix Pharmaceuticals and Tonix Medicines acquired two FDA-approved migraine products from Upsher-Smith Laboratories.