The U.S. Food and Drug Administration (FDA) has approved a new, long-acting oral formulation for the treatment of Parkinson's disease. Developed by Amneal Pharmaceuticals, Crexont aims to offer patients improved symptom control through fewer doses of medication.  

Crexont includes both immediate- and extended-release levodopa plus carbidopa in one pill. The medication aims to alleviate symptoms for longer with fewer doses. Levodopa/carbidopa is commonly used to treat the motor symptoms (tremor, slowness, stiffness) of Parkinson’s disease (PD). Parkinson’s disrupts dopamine production in the brain, leading to the motor symptoms of PD. Levodopa helps temporarily replace some of the lost dopamine; carbidopa helps improve uptake of levodopa.   

The potential promise of the new drug is more “on” time where symptoms are controlled by medication. A Phase III clinical trial found improvements in “on” time with Crexont compared to immediate-release levodopa/carbidopa, and that’s with an average of five doses of the immediate-release compared to only three of Crexont. The new medication led to 0.5 hours of additional “on” time per day, even with fewer doses. An analysis of data following the clinical trial suggests that each individual dose of Crexont may last, on average, about 1.5 hours longer than a dose of immediate-release levodopa.  

This approval comes from the bustling pipeline of PD drugs, with three additional therapies engaged in the regulatory process in 2024. These are just the options to come before the FDA in 2024. Overall, The Michael J. Fox Foundation (MJFF) is monitoring 151 priority treatments in clinical testing for Parkinson’s disease.  

You can read more about what it takes to get a drug approved by the FDA here, and explore more about all the available medications for PD here.