Positive top-line results from IPX066 Phase III study in patients with PD
Published on March 15, 2011 at 12:04 AM
Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced statistically significant, positive, top-line results of the ADVANCE-Parkinson's Disease (PD) Phase III clinical study of the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD)
in advanced PD patients experiencing motor fluctuations. IPX066 is an investigational extended release (ER) CD-LD product. The ADVANCE-PD results demonstrated that IPX066 produced significantly improved control of motor symptoms as compared to IR CD-LD in multiple clinical measures in subjects with advanced PD.
The primary endpoint of this comparison study of IPX066 to IR CD-LD was the percentage of "off time" during waking hours. IPX066 demonstrated a 37% improvement from baseline for IPX066 vs. a 17% improvement from baseline for IR CD-LD (p<0.0001). "Off time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson's symptoms.
The study enrolled 471 subjects on a stable regimen of IR CD-LD who were first entered into a dose-adjustment phase of their IR CD-LD, followed by a conversion to IPX066 after which they were then randomized to either IPX066 or IR CD-LD. Subjects converted to IPX066 experienced a reduction from baseline of more than 2 hours in total "off time" during waking hours, and this effect was maintained in the group then randomized to IPX066 during the blinded study portion. While the group treated with IR CD-LD achieved similar improvement during conversion to IPX066, "off time" worsened by 1.0 hours during double blind treatment with IR CD-LD (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 to an increase of 0.8 hours for IR CD-LD as measured from study entry (p<0.001).