Amneal Pharmaceuticals continues its commitment to the Parkinson’s Disease (PD) community by recently launching CREXONT, a novel oral formulation of carbidopa and levodopa (CD/LD) comprising both immediate-release (IR) granules for rapid onset of action and extended-release (ER) pellets for long-lasting efficacy of the drug. In PD, the second most common neurodegenerative disease after Alzheimer’s disease, the dopamine-producing neurons in the brain die, resulting in slowness of movement, stiffness, resting tremor, and impaired balance. While there is currently no known cure, treatment options are available that help reduce symptoms of PD. The current IR CD/LD drugs are highly effective in early PD patients. However, when approximately 60-80 percent of the dopaminergic cells die due to the progressive nature of the disease, symptoms slowly worsen over time. Patients develop motor fluctuations (dyskinesia) and require more dosing at shorter intervals. CREXONT provides a more robust benefit per dose and reduces motor fluctuations and the number of doses in patients.
More than 10 million people worldwide and approximately 1 million in the U.S. suffer from Parkinson’s Disease (PD). About 90,000 new cases are diagnosed every year in the U.S. and as the longevity of people increases, the Parkinson’s Foundation predicts, there will be 1.2 million PD cases in the U.S. by 2030. Annually, the healthcare cost to PD in the U.S. alone is nearly $52 billion.
In the phase 3 pivotal trial, RISE-PD, patients taking CREXONT on an average of three times daily had a significant 0.5 hours of additional increase in “Good On” time per day without dyskinesia compared to those taking IR CD/LD five times a day. A post-hoc analysis showed CREXONT provides an additional 1.6 hours of “Good On” time per dose compared to IR CD/LD. Although CREXONT can be taken with or without food, for the best efficacy, it is recommended to take the first dose of the day about 1 to 2 hours before eating. The most common side effects of the drug are nausea and anxiety.
CREXONT is Amneal‘s second FDA-approved drug in the PD therapeutic area. Its first product, RYTARY, approved in 2015, is an ER CD/LD and differs in formulation and dosage from CREXONT. With CREXONT already launched in the U.S. market and AbbVie’s subcutaneous 24-hour pump-mediated continuous infusion therapy of foslevodopa and foscarbidopa, Vyalev, recently approved by the FDA, clinicians will soon have more options other than deep brain stimulation to alleviate motor symptoms in advanced stage PD patients.
Dr. Rueben Das, Ph.D.
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