FDA approval for IPX 203 for treatment of Parkinson’s disease to be launched as Crexont (carbidopa and levodopa) extended-release capsules – Amneal Pharma

Amneal Pharmaceuticals, Inc., announced that the FDA has approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets.

“The approval of Crexont is a seminal moment in the treatment paradigm for Parkinson’s disease. The burden of this incurable neurodegenerative disease increases with time. Some PD patients on IR CD/LD take up to 10 daily doses and still experience motor fluctuations. Crexont’s innovative formulation provides a longer duration of “Good On” time with less frequent dosing compared to IR CD/LD.

Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily “Good On” time, defined as “On” time without troublesome dyskinesia, as the disease progresses. There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One new patient is diagnosed with Parkinson’s disease every six minutes. In the treatment of PD, there is a need for improved oral CD/LD formulations that achieve more “Good On” time with fewer daily doses.

Crexont’s therapeutic benefits include: i. More “Good On” time with less frequent dosing: Crexont demonstrated a statistically significant improvement of 0.5 hours of additional “Good On” time per day compared to IR CD/LD, with an average of three times a day dosing with Crexont compared to five times a day dosing with IR CD/LD, in the RISE-PD clinical trial. A post-hoc analysis of the primary endpoint on a per dose basis showed 1.6 hours additional “Good On” time per dose of Crexont, compared to IR CD/LD. ii. Novel formulation designed to provide long lasting efficacy: Crexont is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER pellets with levodopa for long-lasting efficacy. iii. Safety profile consistent with IR CD/LD: The most common adverse reactions with Crexont (incidence greater than 3% and greater than IR CD/LD) are nausea and anxiety.

“The treatment goals for people living with Parkinson’s disease include achieving a more robust duration of benefit per dose of LD, reducing ‘Off’ time, and simplifying dosing regimens. 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, which is very encouraging for both patients and the Parkinson’s community,” said Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida and Director of the Parkinson’s Disease and Movement Disorders Center.

“People living with Parkinson’s disease experience a notable decrease in quality of life over time and they experience more ‘Off’ time and other side effects. As the PD community explores treatment options that address the challenges faced by people with Parkinson’s disease and their families, we champion advances like Crexont that improve ‘Good On’ time, allowing people more time to do the things they love with the people they love,” said Andrea Merriam, Chief Executive Officer of Parkinson & Movement Disorder Alliance.

Amneal expects to make Crexont available to patients in the U.S. in September 2024.