FDA approves Requip for restless legs syndrome
pharmafile | May 12, 2005 | News story | Sales and Marketing |Â Â Â
GlaxoSmithKline's Requip has become the first medicine to receive US approval for the treatment of restless legs syndrome (RLS), after being granted priority review in 2003.
The chronic neurological condition affects as many as 10% of adults in the US and is characterised by uncomfortable and sometimes painful sensations in the legs.
The FDA's approval of Requip (ropinirole) for moderate-to-severe RLS was based on data from three clinical trials in adults diagnosed with the condition. The regulator said these demonstrated a statistically significant difference between the treatment group receiving Requip and a group given placebos.
Chris Viehbacher, president, US Pharmaceuticals, GlaxoSmithKline, said: "With the approval of Requip for moderate-to-severe primary RLS, we're proud to be able to offer effective relief to millions of people who live with this condition, many of whom have suffered for years without treatment."
The drug's label will have to include a warning that Requip has been associated with sedating effects, including sleepiness, as well as the possibility of falling asleep while engaged in activities such as driving.
There were some side-effects reported in the trials and the most common ones included nausea, headache and vomiting.
Requip, which was first approved in the US for Parkinson's disease in 1997, is a second-generation dopamine agonist that directly stimulates dopamine receptors in the brain.
Dr William Ondo, associate professor of Neurology at Baylor College of Medicine, Houston, Texas, said: "Requip targets what doctors believe may be an underlying cause of the disorder, which is dysfunction of a system involving the brain chemical dopamine."
Another dopamine agonist being developed for RLS is Boehringer Ingelheim's pramipexole, which is currently approved for the treatment of Parkinson's disease and marketed by Boehringer under the names Mirapex, Mirapexin and Sifrol.
A recent clinical trial of Boehringer Ingelheim's drug showed that a once-daily dose improved RLS symptoms for a 24-hour period. The study of pramipexole also found it had a rapid onset of action and produced significant improvements in patients' sleep in the trial.
People with RLS often have difficulty falling and staying asleep and can feel less alert during the day, but despite its prevalence, RLS frequently remains under-diagnosed.
The condition is frequently misdiagnosed as a number of other conditions including back pain, depression, arthritis, nocturnal cramps, insomnia and neuropathy.
