Knight Therapeutics Moves Forward with New Parkinson's Treatment
MONTREAL — Knight Therapeutics Inc. (TSX: GUD), a prominent player in the specialty pharmaceutical sector across Latin America, has exciting news! The company's New Drug Submission (NDS) for CREXONT® has received the coveted green light for review from Health Canada.
CREXONT® is an innovative oral treatment combining carbidopa and levodopa (CD/LD) in an extended-release capsule format, specifically designed for patients managing Parkinson’s disease. This state-of-the-art formulation features a unique design that initiates rapid drug release while utilizing a mucoadhesive polymer to gradually release levodopa, allowing for extended absorption in the gut. It's anticipated that CREXONT® will enter a lucrative market, with estimates exceeding $50 million in Canada and over $120 million in Brazil. Notably, the controlled release segment alone accounted for $15 million within Canada during the year leading up to September 2024, as reported by IQVIA.
Earlier this year, in January, Knight Therapeutics made headlines by partnering with Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), granting them exclusive rights to pursue regulatory approval and manage the commercialization of CREXONT® across Canada and Latin America. Moreover, plans are in place to file for marketing authorizations in Mexico and Brazil within the next year.
“The submission of CREXONT® in Canada underscores Knight's unwavering commitment to expanding our central nervous system (CNS) product offerings,” stated Samira Sakhia, President and CEO of Knight Therapeutics. She further emphasized the substantial unmet need in Parkinson’s disease treatment, affirming that CREXONT® will provide a vital new therapeutic option for impacted patients.
About CREXONT®
CREXONT® features an advanced oral formulation of carbidopa/levodopa, consisting of a mix of immediate-release granules and extended-release beads to treat Parkinson’s disease effectively. With immediate-release granules made from carbidopa and levodopa, combined with a disintegrant polymer for swift dissolution, this product stands out in the medicinal market.
It also includes extended-release beads coated with a polymer designed for gradual release, along with a mucoadhesive polymer that helps in adhering to the absorption sites within the gastrointestinal tract, ensuring the effective distribution of the active ingredients. An enteric coating is included to prevent premature disintegration of the granules in the stomach.
The efficacy of CREXONT® has been demonstrated in the RISE-PD clinical study, a comprehensive 20-week trial that engaged 630 participants. This randomized, double-blind, double-dummy, active-controlled phase 3 trial achieved both its primary and secondary endpoints, showcasing that participants who received CREXONT® experienced significant increases in their daily "Good On" time – that is, time free from the symptoms of Parkinson’s disease when taking fewer doses compared to immediate-release formulations. In particular, CREXONT® offered an enhancement of 0.53 hours, with patients consuming the medication an average of three times daily, down from five times for traditional immediate-release carbidopa/levodopa regimens.
The side effects reported with CREXONT®, which notably occurred in 3% or more of users, included nausea and anxiety. It is essential to avoid abrupt cessation of the medication. Patients considering discontinuation should consult with their healthcare professionals to taper the dosage properly, thereby mitigating risks of adverse reactions like fever or confusion.
Understanding Parkinson’s Disease
Parkinson’s disease is recognized as one of the fastest-growing neurological disorders globally, with an estimated 1 million individuals diagnosed in the U.S. alone. In Canada, over 100,000 residents are currently navigating life with Parkinson’s, with about 6,600 fresh diagnoses emerging each year — a rate of approximately 20 new cases for every 100,000 inhabitants. This progressive CNS disorder is marked by degeneration of dopamine-producing neurons, leading to significant impacts on motor control and movement.
Common symptoms include slowed movement, stiffness, resting tremor, and balance impairment. Although not classified as a terminal disease, Parkinson’s carries substantial challenges, leading to considerable disability and associated health concerns. Typically, diagnosis occurs around the age of 60, and as society ages, the number of individuals living with this disease is expected to rise dramatically in the coming decades.
About Knight Therapeutics Inc.
Headquartered in Montreal, Canada, Knight Therapeutics Inc. focuses on acquiring and commercializing specialized pharmaceutical products for Canadian and Latin American markets. The company operates several subsidiaries, including United Medical, Biotoscana Farma, and Laboratorio LKM, expanding its reach across the region. Knight Therapeutics Inc. trades on the TSX under the ticker symbol GUD, and they actively engage in ensuring vital medicines are available for those who need them most.
If you'd like to stay updated on Knight Therapeutics, more information can be found on their official website or by reaching out to their investor relations team.
Frequently Asked Questions
What is CREXONT®?
CREXONT® is a new oral formulation combining carbidopa and levodopa, designed to treat Parkinson's disease more effectively with an extended-release mechanism.
How does CREXONT® differ from traditional treatments?
Unlike standard immediate-release carbidopa/levodopa treatments, CREXONT® offers both immediate and extended release, potentially improving patient management and reducing dosing frequency.
What are the common side effects of CREXONT®?
The most frequently reported side effects include nausea and anxiety. Patients should work with their healthcare providers if they experience adverse effects.
What is the market potential for CREXONT®?
CREXONT® is projected to penetrate substantial markets worth over $50 million in Canada and over $120 million in Brazil.
Who is leading Knight Therapeutics Inc.?
Samira Sakhia is the President and CEO of Knight Therapeutics Inc., guiding the company in its mission to expand its therapeutic portfolio.
