NDA Submitted for IPX066 for Idiopathic Parkinson's Disease
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.
For more information, call (510) 240-6000 or visit www.impaxlabs.com.