Impax announced that it has submitted a New Drug Application (NDA) for IPX066 to the FDA for the treatment of idiopathic Parkinson’s disease. IPX066 is an extended-release capsule formulation of carbidopa-levodopa. The NDA includes data from three controlled Phase 3 studies and two open-label extensions of IPX066 in early and advanced Parkinson’s disease. IPX066 has been studied in about 900 subjects.

IPX066 is intended to maintain consistent plasma concentrations of levodopa for a longer duration vs. immediate release levodopa, which may have an impact on fluctuations in clinical response.

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