On Friday, the U.S. Food and Drug Administration (FDA) approved Tonix Pharmaceuticals Holding Corp.’s TNXP Tonmya (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults.
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, and other symptoms like sleep disturbances and cognitive difficulties.
Tonmya is a non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream.
Tonmya is the first new FDA-approved therapy for fibromyalgia in over 15 years. The approval incorporated efficacy from two Phase 3 clinical trials of nearly 1,000 patients.
Across both Phase 3 trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo.
Across three Phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well-tolerated.
The latest Phase 3 trial, RESILIENT, was recently published in Pain Medicine with data on primary and secondary endpoints measuring pain, patient’s global impression of change, patient-reported symptoms and function, sleep disturbance, and fatigue.
Tonmya is expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of this year.
The company ended the June quarter with cash and cash equivalents of $125.3 million, with cash runway expected to fund operations into the third quarter of 2026.
In June, the U.S. Food and Drug Administration (FDA) sent a “refusal to file” letter to Axsome Therapeutics, Inc. AXSM regarding its AXS-14 (esreboxetine) treatment of fibromyalgia.
The FDA stated that, upon preliminary review, the New Drug Application (NDA) was not sufficiently complete to permit a substantive review.
Over the last six months, Tonix Pharmaceuticals’ stock has jumped over 320%.
Price Action: TNXP stock is trading lower by 8.20% to 47.14 at last check Monday.
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