Impax Pharmaceuticals and GlaxoSmithKline announced positive topline results from its Phase 3 ASCEND-PD trial investigating IPX066 (carbidopa-levodopa extended release capsule) for the treatment of advanced Parksinon’s disease. ASCEND-PD is a randomized, double-blind two-treatment, two-week crossover study in 110 patients evaluating IPX066 compared with a combination treatment of carbidopa-levodopa and entacapone (CLE), and one of three Phase III studies of IPX066. Patients taking a stable dose of CLE were converted to IPX066 over a six-week period, then randomized to one of the two treatments for two weeks and then crossed over to the other treatment for an additional two weeks after a one-week washout with IPX066.
The primary endpoint of this double blind crossover study was the percentage of “off time” during waking hours as measured by patient diary. Patients entered the study with a baseline “off time” of 36.1% (5.9 hours), and at the end of the randomized IPX066 treatment phase patients had “off time” of 24% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for CLE (P<0.0001), representing a 33.5% decrease in percent “off time” for IPX066 from baseline compared with a 10% decrease for CLE.
PX066 is an investigational extended-release capsule formulation of carbidopa-levodopa which is intended to maintain consistent plasma concentration of levodopa for a longer duration versus immediate release levodopa, which may have an impact on fluctuations in clinical response.
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