Knight Therapeutics Files NDS for CREXONT in Canada, Aims to Compete in Over $50 Million Market.

Knight Therapeutics has filed a New Drug Submission for CREXONT, a novel oral formulation of carbidopa/levodopa extended-release capsules for Parkinson's disease treatment. The submission was accepted for review by Health Canada, with a market size of over $50 million in Canada and $120 million in Brazil. Knight has entered into an agreement with Amneal Pharmaceuticals for exclusive rights to seek regulatory approval and commercialize CREXONT in Canada and Latin America.

Knight Therapeutics Inc. (TSX: GUD), a pan-American specialty pharmaceutical company, has announced the filing of its New Drug Submission (NDS) for CREXONT® with Health Canada. CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules designed to treat Parkinson’s disease. The submission marks a significant milestone in the company's ongoing commitment to enhancing its central nervous system (CNS) portfolio.

The innovative design of CREXONT® allows for rapid onset while leveraging a mucoadhesive polymer to facilitate slow LD release, potentially enabling longer LD absorption in the gut. This unique formulation is expected to compete in a market size of over $50 million in Canada and $120 million in Brazil, with the controlled release portion of these markets valued at $15 million each during the twelve-month period ended September 2024, according to IQVIA [1].

In January 2024, Knight Therapeutics entered into an agreement with Amneal Pharmaceuticals Inc. (Nasdaq: AMRX) for exclusive rights to seek regulatory approval and commercialize CREXONT® in Canada and Latin America. The company is also working to submit the marketing authorization application in Mexico and Brazil during 2025.

CREXONT® was studied in the RISE-PD clinical trial, a 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients. The study successfully met its primary and secondary endpoints, demonstrating that treatment with CREXONT® significantly improved daily "Good On" time with fewer doses compared to immediate-release CD/LD. Specifically, CREXONT® showed an improvement of 0.53 hours (least squares mean, 95% CI, 0.09-0.97), with an average dosing frequency of three times per day versus five times per day for IR CD/LD [2].

The most common adverse reactions with CREXONT® (incidence ≥3% and greater than IR CD/LD) are nausea and anxiety. It is recommended to avoid sudden discontinuation or rapid dose reduction with CREXONT®. If discontinuing, healthcare providers should work with patients to taper the dose over time to reduce the risk of fever or confusion.

Parkinson’s disease, a progressive disorder of the CNS affecting dopamine-producing neurons in the brain, is characterized by slowness of movement, stiffness, resting tremor, and impaired balance. While not considered a fatal disease, it is associated with significant morbidity and disability. The average age at diagnosis is 60, and the number of patients living with Parkinson’s disease is predicted to grow significantly over the coming decades [3].

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. The company's shares trade on the TSX under the symbol GUD.

References:
[1] https://finance.yahoo.com/news/knight-therapeutics-announces-filing-drug-110000488.html
[2] https://www.marketscreener.com/news/knight-therapeutics-announces-filing-of-new-drug-submission-for-crexont-carbidopa-and-levodopa-e-ce7c5cdedf8af120
[3] https://www.globenewswire.com/news-release/2025/07/18/3117816/0/en/Knight-Therapeutics-Announces-Filing-of-New-Drug-Submission-for-CREXONT-Carbidopa-and-Levodopa-Extended-Release-Capsules-in-Canada.html