In the trial, all three doses of IPX066 showed improvement compared to placebo.
Impax Pharma said that 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.
According to the company, APEX-PD Phase III IPX066 clinical study results is consistent with the results observed in the UPDRS, 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.
Impax Pharma chief scientific officer Suneel Gupta said that they are thrilled to report these positive results of the APEX-PD trial demonstrating efficacy in early Parkinson’s disease across a range of objective and subjective measures for each of the doses tested.
"We are working diligently to complete the clinical trial program on schedule and target a New Drug Application (NDA) filing by the end of 2011," Gupta said.