Knight submits Crexont Parkinson's drug in Mexico

Executive Summary

• Knight Therapeutics, via its Mexican affiliate Grupo Biotoscana de Especialidad SA de CV, has submitted a marketing authorization application for Crexont (carbidopa/levodopa extended-release capsules) to Cofepris, the Mexican health regulatory agency.
• The submission seeks approval for Crexont to treat Parkinson's disease (PD), postencephalitic parkinsonism, and parkinsonism resulting from carbon monoxide or manganese intoxication in adults.
• This follows previous regulatory milestones, including an exclusive agreement with Amneal Pharmaceuticals for North American/Latin American rights in January 2024 and the acceptance of a similar submission by Health Canada in July 2025.

Key Details

• Regulatory Action: Marketing authorization application submitted to Cofepris (Mexico).
• Product: Crexont, a novel oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules.
• Indications: Treatment of Parkinson's disease, postencephalitic parkinsonism, and parkinsonism following carbon monoxide or manganese intoxication in adults.
• Commercial Rights: Knight Therapeutics holds exclusive rights to seek regulatory approval and commercialize Crexont in Canada and Latin America under an agreement with Amneal Pharmaceuticals Inc. (Nasdaq: AMRX), entered into in January 2024.
• Prior Regulatory Milestones:
  • January 2024: Agreement with Amneal Pharmaceuticals for exclusive rights in Canada and Latin America.
  • July 2025: Submission accepted for review by Health Canada.
• Clinical Data (RISE-PD Study):
  • Study Design: 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients.
  • Primary Endpoint: Successfully met, demonstrating significant improvement in daily "Good On" time with fewer doses compared to immediate-release (IR) CD/LD.
  • Specific Efficacy: Improvement of 0.53 hours (LS mean, 95% CI: 0.09 to 0.97) in "Good On" time.
  • Dosing Frequency: Average of three times per day for Crexont versus five times per day for IR CD/LD.
  • Per-Dose Analysis: Post-hoc analysis showed 1.55 more hours of "Good On" time per dose of Crexont compared to IR CD/LD.
• Market Context: Parkinson's disease is the fastest-growing neurological disorder worldwide; estimated 1 million patients in the US and 500,000 patients aged 45-60 in Mexico.

Notable Quotes

• "This submission of Crexont in Mexico demonstrates Knight's continued execution of our strategy to expand our neurology portfolio," said Samira Sakhia, president and chief executive officer of Knight. "There is a high unmet medical need in the treatment of Parkinson's disease, and we are confident that, with Crexont, we will be bringing a much-needed novel treatment option to Parkinson's patients."