new drug application

Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL, a non-opioid, centrally-acting analgesic for fibromyalgia. The NDA is based on two successful Phase 3 studies showing statistically significant pain reduction. TNX-102 SL has been granted Fast Track designation by the FDA, potentially expediting the review process.

Key points:

The company expects an FDA decision on approval in 2025, pending acceptance of the NDA for review.