Canada considers approval of Parkinson’s therapy Crexont
Extended-release formula aims for consistent symptom control
Health Canada will review Knight Therapeutics’ application seeking approval of Crexont, an extended-release formulation of levodopa and carbidopa aimed at providing steady symptom control in Parkinson’s disease, the company said.
The Parkinson’s therapy is designed to maintain consistent levels of levodopa and carbidopa in the body, prolonging periods of optimal symptom control — known as good on time — with fewer daily doses.
Knight plans to submit regulatory applications for Crexont in Mexico and Brazil this year.
“The submission of Crexont in Canada highlights Knight’s ongoing commitment to enhancing our central nervous system (CNS) portfolio,” Samira Sakhia, Knight’s president and CEO, said in a company press release. “With a significant unmet medical need in Parkinson’s disease treatment, Crexont will offer a valuable new therapeutic option for the patients.”
Parkinson’s therapy has immediate- and extended-release components
Parkinson’s is caused by the progressive loss of dopaminergic neurons, the nerve cells responsible for producing dopamine, a signaling molecule, or neurotransmitter, involved in motor control. The loss of dopamine signaling leads to most Parkinson’s symptoms.
Levodopa is a cornerstone of Parkinson’s treatment, easing motor symptoms by supplying a precursor to dopamine that the brain can convert into the active neurotransmitter. It is typically administered with carbidopa, which prevents levodopa from being converted into dopamine outside the brain.
However, levodopa’s long-term use is associated with off episodes, periods when disease symptoms are not fully controlled between doses, and dyskinesia, or uncontrolled, involuntary movements.
Crexont contains both immediate-release granules of levodopa/carbidopa and extended-release beads of levodopa, ensuring an initial fast release of the medications followed by sustained levodopa release over time.
The therapy is approved in the U.S., based on data from the Phase 3 RISE-PD trial (NCT03670953) showing that Crexont significantly improved daily good on time, with less frequent dosing than traditional immediate-release formulations of levodopa/carbidopa (average of three vs. five daily doses). Crexont also increased good on time by 1.5 hours per dose.
Recent data have also demonstrated the treatment significantly improves sleep quality.
Crexont was developed by Amneal Pharmaceuticals, which has a license agreement with Knight for the treatment’s regulatory approval and commercialization in Canada and Latin America. Amneal continues to market the therapy in the U.S.
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