Knight Therapeutics Announces Filing of New Drug Submission for CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Canada
MONTREAL, July 18, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX:GUD) ("Knight") a pan-American (ex-USA) 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."
About CREXONT®
CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) capsule that combines both immediate-release granules and extended-release beads for the treatment of Parkinson's disease.
CREXONT® contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for gradual drug release, a mucoadhesive polymer designed to prolong adhesion at absorption site, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach.
CREXONT® was studied in the RISE-PD clinical study, which was a 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients.
The RISE-PD study successfully met its primary and secondary endpoints, demonstrating that treatment with CREXONT® significantly improved daily "Good On" time with fewer doses compared to IR 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/LD1. A post-hoc analysis of the primary endpoint on a per dose basis showed 1.55 more hours of "Good On" time per dose of CREXONT®, compared to IR CD/LD2.
The most common adverse reactions with CREXONT® (incidence ≥3% and greater than IR CD/LD) are nausea and anxiety. Avoid sudden discontinuation or rapid dose reduction with CREXONT®. If you are discontinuing CREXONT®, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.
About Parkinson's disease
Parkinson's disease has become the fastest growing neurological disorder worldwide, with approximately 1 million patients diagnosed in the U.S.3,4 As of 2021, over 100,000 people live with Parkinson's disease in Canada, with an estimated 6,600 new diagnoses occurring annually based on an annual incidence rate of 20 new cases per 100,000 people5. It is a progressive disorder of the CNS that affects dopamine-producing neurons in the brain that affect movement.
Parkinson's disease is characterized by slowness of movement, stiffness, resting tremor and impaired balance.6 While Parkinson's disease is not considered a fatal disease, it is associated with significant morbidity and disability.7 The average age at diagnosis for patients with Parkinson's disease is 60; as people live longer, the number of patients living with Parkinson's disease is predicted to grow significantly over the coming decades.3,8
About Knight Therapeutics Inc.
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. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca.
Forward-Looking Statement
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2024, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.
References
- Hauser RA et al. JAMA Neurol. 2023 Oct 1;80(10):1062-1069.
- Hauser RA et al. Neurology 2022;98 (supplement 18).
- Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
- Marras et al. NPJ Parkinsons Dis. 2018;4:21.
- UCB Canada. Parkinson's Disease. UCB Canada. Accessed November 6, 2024. https://www.ucb-canada.ca/en/Patients/Conditions/Parkinson-s-Disease
- NINDS. Parkinson's disease: challenges, progress, and promise. Reviewed August 2019. Accessed April 16, 2021.
- Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
- John Hopkins Medicine. Young-Onset Parkinson's disease. Accessed August 17, 2021.
CONTACT INFORMATION:
| Investor Contact: | ||
| Knight Therapeutics Inc. | ||
| Samira Sakhia | Arvind Utchanah | |
| President & Chief Executive Officer | Chief Financial Officer | |
| T: 514.484.4483 | T. +598.2626.2344 | |
| F: 514.481.4116 | ||
| Email: [email protected] | Email: [email protected] | |
| Website: www.knighttx.com | Website: www.knighttx.com |
