Biogen, Inc. | MedPath

Tonix Pharmaceuticals Seeks FDA Approval for TNX-102 SL in Fibromyalgia

6 months ago

• Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL for the treatment of fibromyalgia. • TNX-102 SL, a non-opioid analgesic, has shown statistically significant pain reduction in two Phase 3 trials for fibromyalgia. • The FDA is expected to decide on the NDA acceptance in December 2024, with a potential approval decision in 2025. • Tonix is also advancing its mpox vaccine candidate, TNX-801, with new data demonstrating tolerability in immunocompromised animals.