FDA Approval Granted for Novel Parkinson’s Treatment

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Amneal Pharmaceuticals Inc. announced yesterday the FDA approval for Parkinson’s drug Crexont (carbidopa and levodopa) via a news release on their website. This novel medication, formerly known as IPX203, combines two common drugs into one capsule.

The FDA originally rejected IPX203 for approval last year because there was insufficient research on the pharmacokinetic data of carbidopa.

This formulation is different from Rytary extended-release capsules, Amneal’s extended-release carbidopa/levodopa treatment for Parkinson’s disease that the FDA approved in 2015. Crexont contains extended-release beads that consist of levodopa, coated with a sustained release polymer, to allow for slow release of the drug. Additionally, this formulation contains immediate-release granules that consist of carbidopa and levodopa, with a disintegrant polymer to allow for rapid dissolution.

The starting dose for Crexont is 35 mg of carbidopa and 140 mg of levodopa twice daily in the form of extended-release capsules and immediate release granules. Dosage can be increased gradually to a dose of 525 mg carbidopa / 2100 mg levodopa four times daily.

Parkinson’s disease is currently the fastest growing neurological disorder worldwide. It affects about 1 million people in the United States with about 90,000 diagnosed every year. It is characterized by tremors, muscle stiffness and impaired balance caused by a decrease in dopamine in the brain. Although it is not fatal, it significantly reduces the quality of life for sufferers. The carbidopa and levodopa combination works because levodopa adds dopamine to the brain and carbidopa maintains the level.

“The approval of Crexont is a seminal moment in the treatment paradigm for Parkinson’s disease,” Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal said in the news release. “The burden of this incurable neurodegenerative disease increases with time. Some PD patients on IR CD/LD 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.”

Crexont can be taken with or without food, but taking it with food may decrease its effect so patients are encouraged to take it at least an hour before eating. The most common side effects were nausea and anxiety, but they were only seen in 3% or fewer patients.

This FDA approval is based on the results of the RISE-PD study, a phase 3 trial held at 105 clinical centers across the United States and Europe.

The commercial release of Crexont in the United States is expected next month.