Amneal receives FDA approval for Parkinson's medication

Earlier this week, the U.S. Food and Drug Administration (FDA) approved a new oral formulation developed by Amneal Pharmaceuticals for the treatment of Parkinson's disease. The medication, named Crexont, is designed to offer significant advantages over existing treatments by combining immediate-release granules with extended-release pellets, thus providing a more sustained therapeutic effect.

Crexont aims to address the conventional limitations associated with current oral Parkinson's treatments, which typically have short-acting effects and necessitate frequent dosing. According to Amneal, patients using these existing treatments often experience motor fluctuations, a common challenge in managing Parkinson's disease. The novel formulation of Crexont is intended to deliver a longer duration of 'good on' time, reducing the frequency of dosing and potentially enhancing the overall quality of life for patients.

This FDA approval marks Amneal's second attempt to bring Crexont to market. The company previously received a Complete Response Letter (CRL) from the FDA last July, indicating that while the safety of levodopa had been established, the safety of carbidopa, the other active ingredient, required further substantiation. The FDA had requested additional information to address these concerns before granting approval.

Historically, in 2015, Impax Pharmaceuticals gained FDA approval for an extended-release capsule combination of carbidopa and levodopa, marketed under the brand name Rytary. Unlike Rytary, Crexont utilizes a different formulation and dosage strength, offering a new therapeutic option for managing Parkinson's motor symptoms.

Amneal has announced plans to make Crexont available to U.S. patients starting this September. This development is poised to provide a new, potentially more effective treatment alternative for those living with Parkinson's disease, addressing some of the critical issues associated with currently available medications.