> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Tonix Drug for Fibromyalgia
- URL: https://www.fdaweb.com/fda-oks-tonix-drug-for-fibromyalgia/
- Published: 2025-08-18T12:00:00.000Z
- Updated: 2026-09-14T15:19:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159706

FDA has approved a Tonix Pharmaceuticals NDA for Tonmya (cyclobenzaprine HCl sublingual tablets), a once-daily, non-opioid drug for treating fibromyalgia in adults. Tonmya is taken at bedtime and uses a sublingual formulation designed for rapid absorption. In clinical trials, the drug was shown to significantly reduce daily pain scores and improve sleep quality, a major issue for many fibromyalgia patients, according to the company.

FDA’s decision was based on data from two Phase 3 randomized, placebo-controlled studies involving nearly 1,000 patients, according to the company. Participants taking Tonmya reported meaningful pain reduction over 14 weeks compared to placebo. A larger proportion also achieved at least a 30% improvement in pain, a benchmark used in chronic pain trials, it says.

Tonix says Tonmya was generally well-tolerated, and the most common side effects included numbness or tingling in the mouth, unusual taste, drowsiness, oral discomfort, fatigue, and dry mouth.

Fibromyalgia affects about four million adults in the U.S., according to the company, adding that symptoms include widespread chronic pain, fatigue, sleep disturbances, and cognitive difficulties.