No Panel Review for Tonix Pharma Fibromyalgia NDA

Tonix Pharmaceuticals says FDA has decided not to require an advisory committee meeting to discuss its recent NDA for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for managing fibromyalgia. If approved, the company says the non-opioid analgesic would be the first new treatment option for fibromyalgia patients in 15 years. The agency has set an 8/15 user fee review action target date.

The NDA is based on data from two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia. The first Phase 3 trial, RELIEF, TNX-102 SL met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo, according to the company. In the confirmatory Phase 3 RESILIENT study, the drug again met the same primary endpoint, it says.