GSK, Impax drug works in Parkinson's study
London, August 17, 2011
An experimental Parkinson's disease drug from GlaxoSmithKline and Impax Laboratories has produced positive results in a second late-stage clinical trial.
The compound, IPX066, which is an extended release version of existing treatment carbidopa-levodopa (CD-LD), significantly improved symptoms in patients with advanced disease compared with standard CD-LD plus entacapone (CLE), the companies said.
The latest results follow success in an earlier phase III study announced in March, paving the way for the new medicine to be submitted for regulatory approval. Impax plans to file IPX066 with the U.S. Food and Drug Administration in the fourth quarter of 2011, while GSK will file it in Europe next year, it said.
GSK bought the rights to the drug from Impax in a deal worth up to $186.5 million last December.
In the latest phase III study, patients on the new drug reduced their "off time" - when the effects of anti-Parkinson's drugs wear off and symptoms return - to 24 percent, or 3.8 hours, during waking hours from 36.1 percent at the start of the trial. Those on CLE still had 32.5 percent "off time", or 5.2 hours.
Full results from the trial will be presented at an upcoming scientific meeting.
Shares in Impax jumped 11 percent in early Nasdaq trade, while GSK was up 1 percent, slightly outperforming a little changed European drugs sector. - Reuters