New Carbidopa/Levodopa Formulation Approved for Reducing OFF Time
Amneal Pharmaceuticals, Inc. announced today that their new medication IPX203, now known as Crexont®, was approved by the Food and Drug Administration.
Crexont is a novel oral formulation of carbidopa-levodopa extended-release capsules. Similar to Amneal’s Rytary, it contains both immediate-release and extended-release elements in the capsule and is designed to increase the length of time that a dose of carbidopa-levodopa is effective, thereby reducing OFF time. However, the mechanism that confers the extended-release nature of Crexont is innovative and unique. Crexont contains a mucoadhesive polymer which keeps the extended-release beads adherent to the area of absorption of carbidopa-levodopa longer.
While carbidopa-levodopa is not a new medication, new formulations of it give people with Parkinson’s disease more options to customize treatment and increase quality of life.
In the pivotal Phase 3 RISE-PD clinical trial, Crexont showed statistically significant improvement in daily good on-time compared to immediate-release carbidopa-levodopa (IR CD-LD) when dosed an average of three times per day compared to five times per day for IR CD-LD. Crexont provided 1.55 more hours of “Good On” time per dose vs IR CD-LD, representing a 70% increase. There were more side effects, including dyskinesia, nausea, dry mouth, and dizziness, among those taking Crexont as compared to those taking the immediate release carbidopa-levodopa.
Crexont has not been compared directly to Rytary in a clinical trial.
Crexont is not yet available in pharmacies. Amneal aims to launch the medication at the end of September. If you have OFF time on your current regimen, talk with your doctor about this potential new option.