Knight Therapeutics Submits CREXONT® Extended-Release Capsules for Review in Canada

Knight Therapeutics Inc., a specialty pharmaceutical firm, has revealed that its New Drug Submission (NDS) for CREXONT® has been officially accepted for evaluation by Health Canada. CREXONT® offers a unique oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules aimed at treating Parkinson’s disease. This cutting-edge design provides a quick onset and employs a mucoadhesive polymer for a sustained levodopa release, which may improve absorption in the gastrointestinal tract over time. The drug is set to tap into a market exceeding $50 million in Canada and over $120 million in Brazil, with the controlled release sector accounting for $15 million in each market during the twelve months ending September 2024, based on IQVIA statistics.

In January 2024, Knight secured an exclusive partnership with Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) to obtain regulatory approval and commercialization rights for CREXONT® in Canada and Latin America. The company is also preparing to submit marketing authorization applications in Mexico and Brazil during 2025.

Samira Sakhia, President and CEO of Knight, commented, “The submission of CREXONT® in Canada underscores our ongoing efforts to strengthen our central nervous system (CNS) portfolio. Addressing the significant unmet needs in Parkinson’s disease treatment, CREXONT® is poised to provide a meaningful new therapeutic choice for patients.”