Impax Pharmaceuticals Reports Results Phase II Parkinson's Trial
IPX066 reduced subjects off time during waking hours by 2 hours compared to Sinemet
Impax Pharmaceuticals has reported the positive results from a recently completed phase II trial of its late-stage Parkinson’s disease drug candidate IPX066.
In the cross-over trial, IPX066 reduced subjects off time during waking hours by 2 hours compared to Sinemet, the standard of care in Parkinson’s disease motor symptom management.
The company said that the detailed results will be presented at the XVIII WFN World Congress on Parkinson’s Disease and Related Disorders in Miami Beach, Florida, December 16 through December 19, 2009.
The trial was a randomised, active-controlled, multi-center, one week per period, crossover study in 27 patients with advanced Parkinson’s disease and compared the efficacy and tolerability of IPX066 to Sinemet.
IPX066 was generally well tolerated and no unexpected treatment-related adverse events were reported in either treatment group, said the company.
IPX066 is an investigational extended release carbidopa-levodopa product intended to produce a fast and sustained concentration of levodopa, potentially improving PD clinical symptom management.
Michael Nestor, president of Impax Pharmaceuticals, said: “We are very encouraged by these Phase II data and the potential for IPX066 to provide improvement over existing regimens in managing motor symptoms of Parkinson’s disease. These results, which include all treated patients, are consistent with the interim data announced earlier this year.”
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