Tonix Pharmaceuticals Holding (NASDAQ: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, has engaged Rho, Inc., a global contract research organization (“CRO”). Under the terms of the engagement, Rho will support Tonix in preparing its New Drug Application (“NDA”) for planned submission to the U.S. Food and Drug Administration (“FDA”) for the clearance of Tonmya(TM), a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, for the management of fibromyalgia.
“We are excited by our most recent positive Phase 3 study results of Tonmya and look forward to Rho’s support in preparing our NDA,” said Seth Lederman, M.D., President and CEO of Tonix. “We intend to meet with the FDA in the first half of this year and to submit our NDA in the second half of the year. We believe we have completed all development work required for the NDA, including CMC requirements and the completion of two positive Phase 3 studies.”
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