Date: 2011-03-14
Type of information: Results
phase: 3
Announcement: results
Company: GSK (UK) Impax Pharmaceuticals (USA - CA)
Product: IPX066 (investigational carbidopa-levodopa (CD-LD) product with an enhanced pharmacokinetic profile)
Action mechanism:
Disease: Parkinson's disease
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country:
Trial
details: 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, then switched to open label IPX066 after which they were then randomised to double-blind IPX066 or IR CD-LD. Subjects switched to IPX066 experienced a total reduction in off-time from baseline of more than 2 hours during waking hours.
Latest
news: GSK announced positive, top-line results of the ADVANCE-Parkinson’s Disease (PD) Phase III clinical study, conducted by Impax Pharmaceuticals, 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 which is being developed by Impax in collaboration with GSK.
The primary endpoint of this study was the percentage of “off time” during waking hours. “Off time” is the functional state when patients’ medication effect has worn off and there is a return of Parkinson symptoms. IPX066 demonstrated a 37% decrease in off-time from baseline vs. a 17% decrease from baseline for IR CD-LD (p<0.0001).
This effect was maintained in those patients randomised to IPX066 during the blinded study portion, while “off time” increased by 1 hour in the group randomised to treatment with IR CD-LD (p<0.0001). In addition, during double-blind treatment, patients on IPX066 experienced an increase of 1.9 hours in “on time” without dyskinesia, compared to an increase of 0.8 hours for IR CD-LD as measured from study entry (p=0.0002).
Efficacy improvements on IPX066 were corroborated by similar improvements in additional clinical and patient-reported outcome endpoints. These included the Unified Parkinson’s Disease Rating Scale (UPDRS), Clinician Global Impression of Change (CGI) and Patient Global Impression of Change (PGI), which also demonstrated significant improvements in treatment with IPX066 compared to IR CD-LD (p
Under the terms of a development and commercialisation agreement, Impax will develop and commercialise IPX066 in the United States and Taiwan, and GSK will develop and commercialise IPX066 in all other markets throughout the world. This agrrement has been concluded in December 2010. Under the terms of the agreement, Impax will complete the current Phase III program for IPX066, which includes the ADVANCE-PD study.
