Study: Investigational GSK, Impax drug reduces Parkinson's symptoms

Phase-3 study of IPX066 shows greater reduction in "off time" versus existing therapy

HAYWARD, Calif. — Patients taking an experimental treatment for Parkinson's disease experienced greater reduction in symptoms than those taking a drug already on the market, according to results of a late-stage clinical trial.

GlaxoSmithKline and Impax Pharmaceuticals announced results of the 110-patient phase-3 "ASCEND-PD" trial of IPX066, an extended-release capsule of the Parkinson's drug carbidopa-levodopa that the companies are comparing with carbidopa-levodopa entacapone, also called CLE. Impax Pharmaceuticals is the branded drugs division of Impax Labs, a generic drug company.

The goal of the study was to reduce "off time," the amount of time during waking hours after a Parkinson's drug has worn off when symptoms of the disease return, with patients entering the study with a baseline off time of 36.1%, or 5.9 hours. Patients taking IPX066 experienced off time of 24%, or 3.8 hours, compared with 32.5%, or 5.2 hours, among patients taking CLE. This represented a 33.5% reduction in off time for IPX066 patients, versus 10% among CLE patients.

"Impax Pharmaceuticals and GSK are excited to report these positive results for the ASCEND-PD trial, which demonstrate an 84-minute improvement in 'off time' over CLE therapy with a corresponding increase in 'on time' without troublesome dyskinesia," Impax Pharmaceuticals chief scientific officer Suneel Gupta said.

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