Phase 3 Study of IPX066 for Advanced Parkinson's Disease

Impax Pharmaceuticals announced positive results from its Phase 3 ADVANCE-PD study of IPX066 (extended-release carbidopa-levodopa) versus immediate-release carbidopa-levodopa in advanced Parkinson's disease patients. The study enrolled 471 patients on a stable regimen of immediate-release carbidopa-levodopa who were first entered into a dose-adjustment phase of their immediate-release carbidopa-levodopa, followed by a conversion to IPX066 after which they were then randomized to either IPX066 or immediate-release carbidopa-levodopa. The primary endpoint of this study was the percentage of “off time” during waking hours.

Patients converted to IPX066 experienced a reduction from baseline of >2 hours in total “off time” during waking hours. This effect was maintained in the group then randomized to IPX066 during the blinded study portion. IPX066 demonstrated a 37% improvement from baseline for IPX066 compared with a 17% improvement from baseline for immediate-release carbidopa-levodopa (p<0.0001). While the group treated with immediate-release carbidopa-levodopa achieved similar improvement during conversion to IPX066, “off time” worsened by 1 hour during double-blind treatment with immediate-release carbidopa-levodopa (p<0.0001). In addition, during double-blind treatment, subjects experienced similar results in “on time” without troublesome dyskinesia with an increase of 1.9 hours for IPX066 compared with an increase of 0.8 hours for immediate-release carbidopa-levodopa as measured from study entry (p<0.001).

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