Tonix Pharmaceuticals Reveals Promising Pharmacokinetics of Cyclobenzaprine for Fibromyalgia in Japan and China
Company: Tonix Pharmaceuticals, Inc.
Indication: Fibromyalgia
Drug: Tonmya™ (TNX-102 SL, cyclobenzaprine HCl sublingual tablets)
Trial Phase: Phase 3
NCT ID: N/A
Overview
Tonix Pharmaceuticals, Inc., a pioneering biopharmaceutical company, disclosed favorable outcomes from its pharmacokinetic bridging study for Tonmya™, designated TNX-102 SL, which is cyclobenzaprine hydrochloride in a sublingual tablet form. This study was specifically geared toward validating the development and commercial partnerships for the drug's introduction in the markets of Japan and China.
The study's compelling positive results exhibited congruent pharmacokinetic parameters of cyclobenzaprine in ethnically Japanese and Chinese cohorts compared to those from a previous study consisting of Caucasian participants. This adjudicates Tonmya™ to be generally well-received among the diverse ethnic backgrounds in terms of safety and tolerability, potentially circumventing the need for dosage adjustments for the Asian demographic.
Key patented market exclusivity rights in Japan, China, Hong Kong, and Taiwan back Tonmya™, which is recognized as a new chemical entity (NCE) in Japan and China, promising exclusivity until at least 2034. The findings of this study aid in fulfilling the prerequisite for a bridging study, thus buttressing regulatory filings for the drug in the targeted markets.
Additionally, these results complement those from the affirmative Phase 3 RESILIENT study, collectively forming a robust clinical evidence base for regulatory submissions. The pharmaceutical company anticipates liaising with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) to accord the procedural advancement of Tonmya™ in the respective nations.
Tonmya™ has emerged as a potential bedrock for the treatment of fibromyalgia, a condition characterized by widespread musculoskeletal pain, by demonstrating statistically significant pain reduction and improvements in sleep quality, fatigue, and overall fibromyalgia symptoms and function in not one but two successful Phase 3 clinical trials.
With the strategic plan to submit a New Drug Application (NDA) to the U.S. FDA in the latter half of 2024, Tonmya™ stands to be a promissory new entrant in the management of fibromyalgia.