FDA Approves Tonix Pharmaceutical’s Fast Track Designation to Tonmya™ as a treatment for fibromyalgia
Tonix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia.
This designation recognises fibromyalgia as a serious condition and indicates that Tonmya could address a significant unmet medical need.
Tonmya is a non-opioid analgesic currently under development specifically for fibromyalgia, a chronic pain condition predominantly affecting women.
The FDA’s Fast Track process is designed to expedite the development and review of therapies for serious conditions. Companies with this designation benefit from more frequent interactions with the FDA during clinical development. Tonix also intends to request Priority Review status for Tonmya, which could further accelerate the NDA review process.
Tonmya is a patented sublingual formulation of cyclobenzaprine hydrochloride intended for bedtime use. It is reported positive topline results from the RESILIENT trial, the second pivotal Phase 3 clinical study of Tonmya for fibromyalgia.
The trial demonstrated a significant reduction in daily pain compared to placebo and met all six key secondary endpoints related to sleep quality, fatigue reduction, and overall improvement in fibromyalgia symptoms.
The first Phase 3 trial, RELIEF, also showed significant results in pain reduction and key secondary outcomes. In both trials, the most common side effect reported was temporary numbness in the mouth or tongue, which was self-limiting and did not lead to severe complications or study discontinuation.
Tonix has reported successful outcomes from two pre-NDA meetings with the FDA and has achieved alignment on various aspects of the NDA submission, including nonclinical, clinical pharmacology, and chemistry, manufacturing, and controls (CMC) features.
