Posted by Michael Wonder on 17 Oct 2024
Tonix Pharmaceuticals announces submission of the TNX-102 SL new drug application for fibromyalgia to the US FDA
16 October 2024 - New drug application 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.
Tonix Pharmaceuticals today announced the submission of a new drug application to the US FDA for TNX-102 SL (cyclobenzaprine hydrochloride sublingual tablets) 5.6 mg, a non-opioid, centrally acting analgesic that showed statistically significant reduction in the chronic, widespread pain associated with fibromyalgia in two Phase 3 studies and was generally well tolerated.
