Impax announced that the FDA has accepted for filing the Company’s New Drug Application (NDA) for IPX066 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 investigated in more than 1,000 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.
For more information, call (510) 240-6000 or visit www.impaxlabs.com.