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Re: mcbio post# 130377

Monday, 11/07/2011 5:08:20 AM

Monday, November 07, 2011 5:08:20 AM

Post# of 257262
Indeed the GSK/IPXL drug had a higher hurdle in that trial for the reason you've mentioned. Moreover, the XP21279 phase 1b trial was an open label study. In its phase II trial IPX066 reduced subjects’ “off” time during waking hours by 2 hours compared to Sinemet (3.8 hours of “off” time for IPX066 vs. 5.8 hours for Sinemet, P<0.0001):

http://www.businesswire.com/news/home/20090921005658/en/Impax-Pharmaceuticals-Reports-Positive-Results-Phase-II

IPX066 first phase III study was vs. placebo, so not that important. This is the PR for the second phase III trial vs. the standard immediate-release carbidopa/levodopa:

http://www.gsk.com/media/pressreleases/2011/2011_pressrelease_10040.htm

Bear in mind that Stalevo (combo of levadopa/carbidopa and entacapone) goes generic in less than a year so cost will play a part in adapting any of these future drugs.

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