« Return to News | Clinical Intelligence

Impax Labs' Parkinson's drug aces late-stage clinical trial

Friday, March 18, 2011 01:41 PM

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.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.