FDA approves new levodopa/carbidopa formulation for use in Parkinson’s

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 Biosciences, Crexont aims to offer patients improved symptom control and a better quality of life through fewer doses of medication.

Crexont is an extended-release formulation of levodopa/carbidopa that aims to alleviate symptoms longer with fewer doses. Levodopa/carbidopa is commonly used to treat Parkinson's disease (PD). Parkinson's disrupts dopamine production in the brain, leading to the motor symptoms most associated with PD. Levodopa helps replace some of the lost dopamine; carbidopa helps improve uptake of levodopa.

The 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 five doses of the immediate-release compared to only three of the extended-release. The new medication led to .5 hours of additional "on time" per day even with fewer doses.

The pill works by maintaining medication in the blood for longer, leading to less frequent dosing.

The 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.