CREXONT has demonstrated a statistically significant improvement in “good on” time for PD patients. Credit: SpeedKingz/Shutterstock.

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals‘ CREXONT extended-release capsules for Parkinson’s disease (PD) treatment.

CREXONT, a new oral carbidopa (CD)/levodopa (LD) formulation, aims to provide patients with more consistent “good on” time, defined as “on” time without troublesome dyskinesia (involuntary movements and muscle spasms).

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It has demonstrated a statistically significant improvement in “good on” time for PD patients.

In the RISE-PD clinical trial, patients experienced 0.5 hours of additional “good on” time per day against immediate-release CD/LD, with CREXONT requiring only three daily doses versus five for the immediate-release version.

A post-hoc analysis revealed 1.6 hours of additional “good on” time per dose of CREXONT.

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The new formulation combines immediate-release granules and extended-release pellets to provide rapid onset and sustained efficacy.

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The safety profile of CREXONT is consistent with that of immediate-release CD/LD, with the most common adverse reactions being nausea and anxiety.

Amneal plans to make the capsules available to US patients in September 2024, offering a new treatment option for the management of PD.

The formulation and dosage strengths differ from RYTARY (carbidopa and levodopa), another extended-release FDA-approved capsule.

Amneal co-CEOs Chirag and Chintu Patel stated: “The approval of CREXONT is a seminal moment in the treatment paradigm for PD. The burden of this incurable neurodegenerative disease increases with time. Some PD patients on IR CD/LD [the mainstays of previous treatments] 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. Amneal is so excited to introduce this meaningful new treatment for Parkinson’s patients in the US and soon internationally.”