GlaxoSmithKline announced the approval of Requip XL (ropinirole extended-release tablets) in the US 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 US 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.
"Many patients require multiple doses of one or more medications to control their Parkinson's symptoms, which makes taking their medicines correctly and at the right times challenging. In addition, patients with Parkinson's disease may have trouble completing routine activities of daily living and self-care," said clinical investigator Rajesh Pahwa, M.D., professor of Neurology and director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas Medical Center in Kansas City. "Requip XL provides continuous delivery of ropinirole over 24 hours to provide smoother blood levels without the peaks and troughs that multiple daily doses typically deliver. It is an important once-daily treatment option for patients with Parkinson's disease."
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.
Requip XL tablets are indicated in the US for the treatment of the signs and symptoms of idiopathic Parkinson's disease and are administered once daily. Prescription Requip XL is not for everyone. Requip XL may cause patients to fall asleep or feel very sleepy during normal activities such as driving; or to faint or feel dizzy, nauseated, or sweaty when they stand up. Patients should tell their doctor if they experience these effects or the following problems, or if they drink alcohol or are taking other medicines that make them drowsy. Side effects may include nausea, dizziness, drowsiness or sleepiness, headache, and sudden uncontrolled movements (dyskinesia). Increase or decrease in blood pressure and heart rate may occur. Hallucinations may occur at anytime during treatment. Patients should also tell their doctor if they experience new or increased gambling, sexual, or other intense urges while taking Requip XL. Requip XL may increase the side effects of l-dopa. Most patients were not bothered enough to stop taking Requip XL.