12/07/2025
A major breakthrough has arrived for the 10 million Americans living with fibromyalgia. On August 15, 2025, Tonix Pharmaceuticals announced that its new sublingual therapy Tonmya has been approved by the FDA — marking the first new fibromyalgia drug in more than 15 years. The medication is now officially available in U.S. pharmacies by prescription, offering long-awaited hope to patients who have had few treatment options.
Tonmya introduces a first-in-class, non-opioid approach to fibromyalgia care. Taken once daily at bedtime, the sublingual tablet works by modulating receptors tied to sleep quality and central pain processing — including 5-HT2A, α1, H1, and M1. Its dual action aims to ease chronic pain and improve nonrestorative sleep, two hallmark challenges of the condition. Notably, it avoids opioid pathways entirely, aligning with a growing national push toward safer pain treatments.
The FDA’s approval was driven by strong results from two Phase 3 trials — RELIEF and RESILIENT — which enrolled nearly 1,000 participants. Patients taking Tonmya showed significant reductions in daily pain scores over 14 weeks versus placebo, and more of them reached the important benchmark of a ≥30% reduction in pain after three months.
Tonix CEO Seth Lederman called the approval a long-awaited victory for patients and a milestone for the non-opioid pain field. It follows another recent industry milestone: the approval of Vertex’s suzetrigine (Journavx™), the first new oral non-opioid analgesic in decades.
The fibromyalgia and chronic pain landscape is now shifting toward multi-mechanistic science and rapid innovation. Leaders from Tonix, Vertex, Eli Lilly, AbbVie, Novartis, and Merck will gather this January at the Non-Opioid Pain Therapeutics Summit to discuss emerging targets, clinical trial advancements, and what’s next for pain medicine.