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Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ for the Treatment of Fibromyalgia
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Tonix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. This is a significant development, as it is the first new FDA-approved therapy for this chronic pain condition in over 15 years. Fibromyalgia, which affects over 10 million adults in the U.S. (mostly women), causes widespread pain, sleep disturbances, fatigue, and other debilitating symptoms.

The approval of Tonmya was based on the positive results from two pivotal Phase 3 clinical trials, known as RELIEF and RESILIENT, which included nearly 1,000 patients. In both studies, Tonmya, administered as a once-daily bedtime dose, significantly reduced patients' daily pain scores compared to a placebo after 14 weeks. A greater percentage of patients taking Tonmya also reported a clinically meaningful improvement in their pain after three months.

Across a total of three Phase 3 trials involving over 1,400 patients, Tonmya was found to be generally well-tolerated. The most common side effects included numbness or discomfort in the mouth, abnormal taste, drowsiness, tingling, and dry mouth. According to healthcare professionals, the sublingual formulation of Tonmya is designed to reduce pain quickly and durably, bypassing liver metabolism that can affect a medicine's efficacy and safety over time.

Tonmya is a first-in-class, non-opioid analgesic that targets the non-restorative sleep characteristic of fibromyalgia, which can improve core symptoms, particularly pain.

The CEO of Tonix Pharmaceuticals, Dr. Seth Lederman, and the founder of the Fibromyalgia Association, Sharon Waldrop, both highlighted the approval as a landmark advancement that brings renewed hope to a community that has been underserved for many years. Tonix Pharmaceuticals expects to make Tonmya available to patients in the fourth quarter of this year. The company will also host a webcast and conference call on August 18, 2025, to provide further details about the approval and the commercial launch. The patents for Tonmya's unique formulation are expected to provide U.S. market exclusivity until at least 2034, with potential extensions.

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