FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

On August 15, 2025, the FDA approved Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine HCl sublingual tablets) as the first new treatment for fibromyalgia in over 15 years1345.

Tonmya is a non-opioid, once-daily analgesic formulated for sublingual use (dissolves under the tongue) for rapid absorption23.

Two pivotal phase 3 clinical trials showed Tonmya significantly reduced fibromyalgia pain compared to placebo, with a greater percentage of patients achieving clinically meaningful improvements45.

Fibromyalgia affects an estimated 10 million adults in the US, mainly women, causing widespread pain, fatigue, sleep disturbances, cognitive issues, and mood symptoms235.

Tonmya was generally well tolerated in trials; common side effects (≥2%) included oral hypoesthesia, discomfort, abnormal taste, somnolence, and dry mouth4.

Tonix holds patents protecting Tonmya in the US until at least 2034, with possible extensions through 20442.

Commercial availability of Tonmya is expected in the fourth quarter of 202535.

Sources:

1. https://www.fiercepharma.com/pharma/tonixs-tonmya-gains-fda-nod-becoming-first-new-fibromyalgia-treatment-more-16-years

2. https://clival.com/news/tonix-wins-fda-approval-for-tonmya-the-first-new-fibromyalgia-drug-in-15-years

3. https://ir.tonixpharma.com/news-events/press-releases/detail/1585/tonix-pharmaceuticals-announces-fda-approval-of

4. https://www.psychiatrictimes.com/view/fda-approves-tonmya-first-fibromyalgia-medication-in-15-years

5. https://www.globenewswire.com/news-release/2025/08/15/3134450/28908/en/Tonix-Pharmaceuticals-Announces-FDA-Approval-of-Tonmya-cyclobenzaprine-HCl-sublingual-tablets-for-the-Treatment-of-Fibromyalgia.html