Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). Crexont is a novel oral formulation combining immediate-release (IR) granules and extended-release (ER) pellets.
Clinical Benefits of Crexont
Crexont aims to address the limitations of existing oral IR CD/LD products, which are short-acting and can lead to motor fluctuations and reduced 'Good On' time for patients. The new formulation is designed to provide longer-lasting efficacy with less frequent dosing.
In the RISE-PD clinical trial, Crexont demonstrated a statistically significant improvement of 0.5 hours of additional 'Good On' time per day compared to IR CD/LD. Patients averaged three times a day dosing with Crexont compared to five times a day dosing with IR CD/LD. A post-hoc analysis indicated 1.6 hours additional 'Good On' time per dose of Crexont compared to IR CD/LD.
Formulation and Safety
Crexont consists of IR granules with carbidopa and levodopa for rapid onset and ER pellets with levodopa for extended efficacy. The most common adverse reactions reported were nausea and anxiety, with a safety profile consistent with IR CD/LD.
Expert Commentary
Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida, noted that Crexont's longer 'Good On' time per day and per dose represents a substantial advancement in managing motor symptoms and maintaining more consistent therapeutic effects.
Andrea Merriam, Chief Executive Officer of Parkinson & Movement Disorder Alliance, highlighted the importance of advances like Crexont that improve 'Good On' time, allowing people more time to do the things they love.
Availability
Amneal expects to make Crexont available to patients in the U.S. in September 2024.
Parkinson’s Disease Context
Parkinson’s disease is the fastest-growing neurological disorder worldwide, affecting approximately one million people in the U.S., with 90,000 new cases diagnosed each year. It is a progressive disorder of the central nervous system affecting dopamine-producing neurons, leading to motor symptoms such as slowness of movement, stiffness, tremor, and impaired balance.
