The Committee for Medicinal Products for Human Use (CHMP) has reached a positive opinion for Adartrel (active ingredient: ropinirole) for the symptomatic treatment of moderate to severe idiopathic RLS (restless legs syndrome). This action is the first step in gaining national marketing authorisations for ropinirole as a treatment for RLS in the member states of the European Union, Norwayand Iceland, GlaxoSmithKline plc announced here.
Ropinirole is currently marketed as Adartrel for the treatment of RLS in Franceand Switzerland. The drug is also marketed for the treatment of RLS under the name, Repreve, in Australia, and Requip in the United States.
“We are pleased that the CHMP agrees that ropinirole delivers benefit to patients with moderate to severe RLS who typically suffer with insomnia or have severe discomfort in their limbs,” said Ronald Krall, senior vice president, Worldwide Development, GSK. “Data show that ropinirole is effective in treating the primary sensorimotor symptoms of RLS thereby reducing sleep disturbance, promoting sleep, and improving the quality of life of patients with RLS,” he added.
Ropinirole is a synthetic dopamine agonist that acts by ‘mimicking’ dopamine in the brain, thereby increasing the activity of neurotransmission. While the primary cause of RLS is unclear, there is evidence that it may be related to abnormalities in the central dopaminergic system in the brain. Dopamine is a monoamine neurotransmitter essential to the normal functioning of the central nervous system.
Ropinirole has also been available in Europe as Requip since 1996 for the treatment of Parkinson’s disease.
RLS is a neurological movement disorder characterised by an uncontrollable urge to move the legs and painful or distressing sensations in the lower limbs that are sometimes described by patients as creeping, crawling, burning or pulling. Movement can provide temporary relief. Symptoms of RLS occur during rest, often in the evening or at night leading to patients having difficulties in initiating and maintaining sleep.