Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya as Proposed Brand Name for Cyclobenzaprine HCl Sublingual Tablets, 2.8 mg

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Tonix Pharmaceuticals Holding Corp.
TNXP
("Tonix") today reported that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proposed trade name Tonmya™ (ton-MY-ah) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, for the management of fibromyalgia. Tonix recently launched the Phase 3 AFFIRM study of Tonmya in fibromyalgia, from which top-line results are expected to be reported in the second half of 2016. A request for proprietary name review for Tonmya will be submitted once the fibromyalgia New Drug Application (NDA) is submitted. FDA's final approval of Tonmya is subject to NDA approval. Tonix has applied to the U.S. Patent and Trademark Office to obtain federal registration of the Tonmya mark.
Posted In: NewsFDAPress Releases
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