NDA Accepted for IPX066 for Idiopathic Parkinson's Disease
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.