Tonix Pharmaceuticals Holding Corp. announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya? (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia.

At the meeting, the Company and the FDA agreed that the proposed data package is sufficient to support the NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024 which would allow for a potential FDA approval in the second half of 2025. On June 20, 2024, Tonix announced receipt of formal minutes of a pre-NDA Type-B Chemistry, Manufacturing, and Controls (CMC) meeting confirming alignment with the FDA on key CMC topics to support the NDA submission.

Today?s announcement confirms alignment with the nonclinical, clinical pharmacology and clinical features of the NDA submission, following completion of Tonix?s second and final pre-NDA meeting.