Tonix Application (NDA) for Fibromyalgia

 NDA based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant results on the primary endpoint of reducing widespread pain; generally well tolerated

TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA

Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women

If approved by FDA, TNX-102 SL would be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years

https://www.globenewswire.com/news-release/2024/10/16/2963986/28908/en/Tonix-Pharmaceuticals-Announces-Submission-of-the-TNX-102-SL-New-Drug-Application-NDA-for-Fibromyalgia-to-the-U-S-Food-and-Drug-Administration-FDA.html