FDA Approval Granted for Novel Parkinson’s Treatment

Amneal Pharmaceuticals Inc. announced yesterday that the FDA has approved Crexont (carbidopa and levodopa) for the treatment of Parkinson’s disease. This new medication, previously known as IPX203, combines two commonly used drugs into a single capsule. The FDA initially rejected IPX203 last year, citing a lack of sufficient research on the pharmacokinetics of carbidopa. Crexont's formulation differs from Rytary, Amneal’s other extended-release carbidopa/levodopa treatment approved by the FDA in 2015. Crexont includes extended-release beads of levodopa, coated with a sustained-release polymer for gradual drug release, as well as immediate-release granules containing both carbidopa and levodopa, designed for rapid dissolution. The recommended starting dose of Crexont is 35 mg of carbidopa and 140 mg of levodopa, taken twice daily as extended-release capsules and immediate-release granules. The dosage can be gradually increased to a maximum of 525 mg of carbidopa and 2100 mg of levodopa, taken four times daily. “The approval of Crexont marks a pivotal moment in the treatment of Parkinson’s disease,” stated Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, in the news release. “As the burden of this incurable neurodegenerative disease grows over time, some patients taking IR CD/LD need up to 10 daily doses yet still experience motor fluctuations. Crexont’s innovative formulation offers longer ‘Good On’ time with fewer doses compared to IR CD/LD.” Crexont can be taken with or without food, though taking it with food may reduce its effectiveness, so patients are advised to take it at least an hour before eating. The most common side effects reported were nausea and anxiety, affecting 3% or fewer patients. The FDA approval is based on the results of the RISE-PD study, a phase 3 clinical trial conducted at 105 centers across the United States and Europe. Crexont is expected to be commercially available in the United States next month.