Impax Laboratories LLC (now Amneal)
This is a multi-center (89 locations), randomized, double-blind, double-dummy, active-controlled, parallel-group study. It will consist of a 3-week, open-label IR CD-LD dose adjustment period; a 4-week, open-label period for conversion to IPX203; followed by a 13-week double-blind treatment period with subjects randomized in a 1:1 ratio, stratified by center, to receive either IPX203 (with matching IR CD-LD placebo) or IR CD-LD (with matching IPX203 placebo).
The primary outcome is the change in “good ON” time. Secondary outcome measures are the change in OFF time; patients rated as “much improved” or “very much improved” in Patient Global Impression of Change (PGI-C); change in UPDRS Part III; and change in UPDRS Parts II and III. All the outcome measures will be assessed at the end of the double-blind study period at 13 weeks.
While symptomatic therapies for PD are easier to develop than drugs to modify the course of the disease, easier does not mean easy. This reality is underlined by the recent failure of the previously featured Phase 3 study of Intec Pharma’s Accordion Pill to reach its primary outcome objectives . The Accordion Pill LD/CD containing both immediate and controlled release forms, presented with a unique gastric retentive drug delivery system which allowed for slow release of LD/CD in the stomach. According to the company website, on preliminary review, the study failed to demonstrate a statistically significant difference in OFF times as compared to the IR CD/LD arm. Further analysis and publication of data are pending . The Phase 3 trial of IPX203 is thus a large and comprehensive program with a randomized, double-blind, double-dummy, active-controlled, parallel-group study design. The company’s experience with Rytary (codenamed IPX066 when in development) will be invaluable for the successful implementation of this pivotal Phase 3 study. While not groundbreaking, if successful, a new oral formulation of LD/CD with a longer duration of action will be a welcome addition to the armamentarium of available treatment options for PwPs.