Tonix Pharmaceuticals announces FDA acceptance of NDA for TNX-102 SL

Tonix Pharmaceuticals (TNXP) announced that the U.S. Food and Drug Administration, FDA, has accepted the filing of its New Drug Application, NDA, for TNX-102 SL, a 5.6 mg, non-opioid, centrally-acting analgesic, for the management of fibromyalgia. The FDA is expected to assign the NDA a Prescription Drug User Fee Act, PDUFA, target action date in a Day 74 Letter. At that time, the FDA will also communicate to Tonix whether Priority Review has been granted. TNX-102 SL was granted Fast Track designation for fibromyalgia by the FDA in July of 2024. Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.