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HAYWARD, Calif. — The branded subsidiary of Impax Labs has submitted a new drug application for its investigational idiopathic Parkinson's disease treatment to the Food and Drug Administration.
Impax Pharmaceuticals said Wednesday that IPX066 — an extended-release capsule formulation of carbidopa-levodopa — has undergone several studies in patients that have early and advanced stages of the disease. IPX066 is not approved or licensed anywhere in the world, the drug maker said, but the company did note that the drug is being developed in collaboration with GlaxoSmithKline for territories outside the United States and Taiwan.
“In just three-and-a-half years, Impax’s brand research and development team has successfully advanced IPX066 from an investigational new drug through multiple clinical studies of efficacy and safety, culminating in our NDA submission,” Impax Pharmaceuticals president Michael Nestor said. “This event demonstrates our strong internal capability to develop neurology products to fulfill unmet clinical needs of the PD community. IPX066 represents a significant commercial opportunity for Impax in the U.S., which if approved we plan to commercialize with our specialty neurology sales team.”