Hayward, Calif.-based Impax Laboratories said the Parkinson's drug it in-licensed from GlaxoSmithKline last year—its second attempt at an extended-release version of caribidopa-levadopa—beat out the standard of care for controlling a key symptom of the disease in a late-stage study, according to FiercePharma.
The primary endpoint of the IPX066 trial was the percentage of "off time"—when patients' medication effect has worn off and there is a return of Parkinson's symptoms—during waking hours. IPX066 demonstrated a 37% improvement from baseline compared to a 17% improvement from baseline for the standard treatment.
"With the successful completion of this ADVANCE-PD trial and the APEX-PD trial in patients with early PD, we have completed the two required phase III trials for a New Drug Application as agreed with the FDA. We are working diligently to file an NDA in the fourth quarter of 2011," said Impax CSO Dr. Suneel Gupta.
Just three months ago GlaxoSmithKline signed a $186 million licensing deal for the program, gaining ex-U.S. rights with an $11.5 million upfront payment and a promise of $175 million in milestones.
The FDA rejected a similar product from Impax, Vadova, in early 2008. A few months later the company announced plans to launch a new development program to create a next-generation carbidopa-levodopa therapy that could leverage the experience it had gained trying to get an approval for Vadova.
