Impax's NDA for idiopathic PD drug accepted for review
Thursday, February 23 2012 | Comments
The Food and Drug Administration
accepted for filing the New Drug Application (NDA) for Impax Pharmaceuticals
' IPX066 as a treatment for idiopathic Parkinson's disease (PD).
The NDA for IPX066, a patented, extended-release capsule formulation of carbidopa-levodopa, contained findings from three controlled Phase III trials and two open-label extension studies of IPX066 in both early and advanced PD. According to Impax, the drug has been investigated in more than 1,000 individuals.
The FDA is scheduled to decide on the approval of IPX066 by Oct. 21.
Impax Pharmaceuticals, the branded products division of Impax Laboratories Inc.
, and GlaxoSmithKline Plc
(GSK) entered into an agreement in 2010 to develop and commercialize IPX066. The agreement provided GSK with an exclusive license to register and commercialize IPX066 in countries other than the United States and Taiwan. Impax will be responsible for commercializing the drug in the United States if it is approved.