GlaxoSmithKline has received approval of Requip XL(ropinirole extended-release tablets) in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. It is the first and only oral once-daily non-ergot dopamine agonist indicated for Parkinson’s disease. The product should be available in U.S. pharmacies in mid-July 2008.
Patients with Parkinson’s disease may experience what is commonly known as “off” time when their medication wears off and their symptoms return. Symptoms such as slowness of movement, tremor, and rigidity can be problematic for these patients, causing simple activities and movement to become difficult. Results from a pivotal efficacy and safety trial showed that adding extended-release ropinirole to patients’ existing levodopa (l-dopa) therapy reduced the amount of “off” time experienced by patients with Parkinson’s disease by 2.1 hours per day on average, compared to baseline. Specifically, comparing the experience of the group treated with extended-release ropinirole versus the placebo group, the adjusted mean difference in the reduction of “off” time was -1.7 hours, which was statistically significant.
Requip XL is an extended-release, once-daily tablet formulation that uses SkyePharma PLC’s (LSE: SKP) patented GEOMATRIX™ technology. This innovative tri-layer formulation allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels. Extended-release ropinirole offers physicians and patients a simple titration regimen; it also offers a convenient, once-daily dosing schedule compared to other oral dopamine agonists, which are dosed multiple times a day.
FDA approval was based primarily on results from the EASE-PD (Efficacy And Safety Evaluation in Parkinson Disease) Adjunct Study, a multi-center, double-blind, placebo-controlled study conducted in patients with idiopathic Parkinson’s disease not adequately controlled with l-dopa. A total of 393 patients in the study were randomized to receive either extended-release ropinirole(n=202) or placebo (n=191) once daily for 24 weeks in addition to l-dopa. The study’s primary endpoint was the mean change from baseline at week 24 in awake time spent “off”, which was measured via patient diaries. Results from the study showed that extended-release ropinirole significantly reduced “off” time by an average of 2.1 hours per day from baseline, compared to a reduction of 0.4 hours per day for placebo. Once-daily use of extended-release ropinirole was generally well tolerated in the study. The withdrawal rate due to adverse reactions was low and similar between groups (6 percent extended-release ropinirolevs. 5 percent placebo).