Knight Therapeutics Inc. specialty pharmaceutical company, announced today that Knight's New Drug Submission (NDS) for CREXONT® has been accepted for review by Health Canada.
CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease. The innovative design of CREXONT® allows for rapid onset, while leveraging a mucoadhesive polymer for slow LD release, potentially enabling longer LD absorption in the gut. CREXONT® is expected to compete in a market size of over $50 million in Canada and over $120 million in Brazil. In each of these markets, the controlled release portion of the market was $15 million, during the twelve-month period ended on September 2024, according to IQVIA.
In January 2024, Knight announced that it had entered into an agreement with Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal") for the exclusive rights to seek regulatory approval and commercialize CREXONT® in Canada and Latin America. Knight is also working to submit the marketing authorization application in Mexico and Brazil during 2025.
"The submission of CREXONT® in Canada highlights Knight's ongoing commitment to enhancing our central nervous system (CNS) portfolio," said Samira Sakhia, President and CEO of Knight. "With a significant unmet medical need in Parkinson’s disease treatment, CREXONT® will offer a valuable new therapeutic option for the patients."
