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news.Tonix Pharmaceuticals has revealed that the US Food and Drug Administration (FDA) has conditionally accepted the proposed trade name Tonmya for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of posttraumatic stress disorder (PTSD).
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Tonix recently launched the Phase 3 HONOR study of Tonmya in military-related PTSD, from which topline results are expected to be reported in the second half of 2018.
Tonmya was designated a Breakthrough Therapy by the FDA for the treatment of PTSD.
A request for proprietary name review for Tonmya will be submitted once the PTSD New Drug Application (NDA) is submitted. FDA's final approval of Tonmya is subject to NDA approval.
A request for review of Tonmya as the proposed name for TNX-102 SL for the management of fibromyalgia has been withdrawn at the FDA. The U.S. Patent and Trademark Office has granted the federal registration of the Tonmya mark.