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news.Impax Pharmaceuticals has submitted its New Drug Application (NDA) for IPX066 to the US FDA indicated in the treatment of idiopathic Parkinson's disease (PD).
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IPX066 is a patented extended release capsule formulation of carbidopa-levodopa (CD-LD), intended to maintain consistent plasma concentration of levodopa.
The NDA includes data from three controlled Phase III studies and two open label extensions of IPX066 in early and advanced PD.
Impax Pharmaceuticals president Michael Nestor said the regulatory move reflects the company’s commitment to develop neurology products.
"IPX066 represents a significant commercial opportunity for Impax in the US, which if approved we plan to commercialize with our specialty neurology sales team," Nestor added.
The drug candidate is developed by Impax along with GlaxoSmithKline (GSK) for territories outside the US and Taiwan.