Impax Pharmaceuticals, the brand products division of Impax Laboratories, has started a Phase III trial of IPX066 in Parkinson’s disease or PD patients based on encouraging interim data collected from the Phase II study in PD patients. It also clarified the FDA requirement for pediatric studies of its investigational medication IPX056.
The Apex-PD study is a Phase III randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of IPX066 in subjects with PD. The study will evaluate three doses of IPX066 versus placebo in subjects with mild symptoms of PD.
The trial is expected to enroll approximately 350 subjects who will be randomized into one of four treatment groups. The trial will be conducted at multiple sites in North America and Europe. The agreed upon primary endpoint is change from baseline in the sum of unified Parkinson’s disease rating scale parts II and III. Additional endpoints include clinical and patient reported outcome measures.
IPX066 is an investigational extended release carbidopa levodopa product intended to produce a fast and sustained concentration of levodopa, potentially improving PD clinical symptom management.
Impax is planning to commence a second Phase III trial of IPX066 in patients with advanced PD patients later in 2009 or early 2010.
Larry Hsu, president and CEO of Impax Laboratories, said: We are very pleased to report these recent achievements, which are important to our long term strategy of investing in developing branded pharmaceutical products.
We believe this strategy will augment our generic business and propel our company to the next growth phase by providing longer-life-cycle products with significantly higher margin potential than our generic products.