Tonix Pharmaceuticals Receives FDA Approval for Fibromyalgia Treatment Tonmya

Tonix Pharmaceuticals has received FDA approval for Tonmya, a cyclobenzaprine sublingual tablet for fibromyalgia treatment. Tonmya is the first new treatment for the condition in over 15 years. It is taken sublingually and has shown promise in reducing pain and improving function in patients with fibromyalgia.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced that the U.S. Food and Drug Administration (FDA) has approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. This approval marks the first new FDA-approved therapy for fibromyalgia in over 15 years [1].

Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S., predominantly women. The condition is characterized by chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness, among other symptoms. Tonmya, a first-in-class, non-opioid, once-daily bedtime analgesic, is designed to provide rapid absorption into the bloodstream via a unique sublingual formulation [1].

The FDA approval is based on the results of two pivotal Phase 3 clinical trials, RELIEF and RESILIENT, which enrolled nearly 1,000 patients in total. Both trials demonstrated that Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of participants taking Tonmya experienced clinically meaningful improvement in their pain after three months [1].

Tonmya was generally well tolerated, with the most common adverse events including oral hypoesthesia, oral discomfort, and somnolence. The drug is expected to be commercially available in the fourth quarter of 2025 [1].

Tonix Pharmaceuticals, a fully-integrated biotechnology company, will host a webcast and conference call on Monday, August 18, 2025, at 8:30 AM ET to discuss the approval of Tonmya. For more information, visit TonmyaHCP.com [1].

References:
[1] https://finance.yahoo.com/news/tonix-pharmaceuticals-announces-fda-approval-194400374.html