Phase 3 study of IPX066 for the treatment of Parkinson's disease (PD)

Impax Pharmaceuticals announced results from its Phase 3 study of IPX066 for the treatment of Parkinson's disease (PD).  This trial was a randomized, double-blind, placebo controlled, parallel group, fixed-dose study comparing 3 doses of IPX066 to placebo in patients with early Parkinson's disease. The trial met its primary efficacy endpoint of change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III score at end of study. The UPDRS Part II measures the activities of daily living and the UPDRS Part III measures motor symptoms of PD. All three doses of IPX066 showed significant improvement compared to placebo (p<0.0001 for all treatments). The mean sum of Parts II and III UPDRS score on IPX066 treatment improved 13.2 units (36%) compared to an improvement of 0.6 units (2%) with placebo treatment, indicating a major improvement in PD symptom severity in early PD patients as a result of IPX066 treatment.

IPX066 also demonstrated mean improvements of 72% in both Clinician Global Impression of change (CGI) and Patient Global Impression of change (PGI) compared to improvements of 27% and 34% for placebo in CGI and PGI, respectively (p<0.0001 for both measures at all three dose levels). In addition, IPX066 treatment resulted in an improvement over placebo in quality of life as measured by the Parkinson's Disease Questionnaire (PDQ-39) at week 30 (p<0.02).

IPX066 is an investigational extended-release carbidopa-levodopa product designed to produce a fast and sustained concentration of levodopa, potentially improving PD clinical symptom management.

For more information call (215) 289-2220 or visit www.impaxlabs.com.