FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson’s Disease
- Category: Small Molecules
- Published on Thursday, 23 February 2012 16:19
- Hits: 224
PDUFA Date Set for October 21, 2012
HAYWARD, CA, USA I February 23, 2012 I Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for IPX066 for the treatment of idiopathic Parkinson’s disease (PD) submitted to the Agency on December 21, 2011. IPX066 is a patented extended release capsule formulation of carbidopa-levodopa (CD-LD). The Prescription Drug User Fee Date (PDUFA) for a decision by the FDA is October 21, 2012. IPX066 has been licensed to GlaxoSmithKline (GSK) for countries outside the U.S. and Taiwan for development and marketing.
IPX066 has undergone extensive clinical development, including multiple studies in early and advanced PD in the U.S. and in Europe. The NDA included data from three controlled Phase III studies and two open label extensions of IPX066 in both early and advanced PD. IPX066 has been investigated in more than 1,000 subjects.
IPX066 is an investigational extended release capsule formulation of CD-LD which is intended to maintain consistent plasma concentration of levodopa for a longer duration versus immediate release levodopa, which may have an impact on fluctuations in clinical response. It is not approved or licensed anywhere in the world.
Results from the pivotal phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced. Results of the ASCEND-PD study have been accepted for presentation to the American Academy of Neurology April 2012.
About the Impax GSK collaboration
Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066 in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan.
About Parkinson’s Disease
Parkinson’s disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax is headquartered in Hayward, California, with a full range of capabilities located in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
SOURCE: Impax Laboratories