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BY OUR PHARMA CORRESPONDENT
18 September,2005: Ropinirole has been recommended for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome by the Committee for Medicinal Products for Human Use (CHMP), GlaxoSmithKline plc (GSK) announced.
If approved, it will be the first step in gaining national marketing authorisations for Ropinirole as a treatment for
Restless Legs Syndrome (RLS) in the member states of the European Union, Norway and Iceland. This could make Ropinirole the first widely available treatment for people suffering from the symptoms of RLS in Europe.
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. Ropinirole is currently marketed as Adartrel for the treatment of RLS in France and Switzerland.
The drug is also marketed for the treatment of RLS under the name, Repreve, in Australia, and Requip in the United States.
RLS patients do not get a restful night’s sleep and therefore the following day are exhausted, have difficulty concentrating and show reduced interest in normal daily activities. 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, said a GSK release.
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.2 Dopamine is a monoamine neurotransmitter essential to the normal functioning of the central nervous system.
Ropinirole has also been available in Europeas Requip since 1996 for the treatment of Parkinson’s disease.
- Individuals with RLS often experience severe sleep impairment resulting in daytime fatigue. Approximately 80 percent of people with RLS have involuntary repetitive movements called periodic limb movements during sleep that typically occur every 20 to 30 seconds on and off throughout the night contributing to sleep disturbance.
· Findings from the RLS Epidemiology, Symptoms and Treatment (REST) study, the largest and most comprehensive study of the prevalence, burden and diagnosis of RLS across Europe and the U.S., show that most patients who seek medical advice for
RLS symptoms are misdiagnosed and continue to suffer from the distressing condition. In the survey of patients with RLS symptoms, 65 percent reported consulting a physician about their symptoms during the past 12 months; of those, 58 per cent reported receiving a diagnosis, but only 12.9 percent reported being diagnosed with RLS. Those who were misdiagnosed had their symptoms wrongly attributed to such conditions as varicose veins or lower back problems.
Researchers have concluded that RLS often runs in families which would imply a genetic element however this is not always the case and the condition can occur sporadically.
Physicians diagnose RLS based on a discussion with the patient on their symptoms. Currently, no laboratory tests can confirm the diagnosis of RLS.
Clinical trials have assessed the benefit of ropinirole in improving RLS symptoms. Pooled data for moderate to severe RLS patients across trials indicate:
- Ropinirole significantly improved sleep parameters (as measured by the Medical Outcomes Study Sleep scale) - sleep disturbance, sleep quantity, sleep adequacy and daytime somnolence at week 12 compared to placebo (p<0.0001).
- Ropinirole significantly improved RLS symptoms (as measured by the International Restless Leg scale) compared to placebo (treatment difference for mean change from baseline at week 12 -4.0, p<0.0001).
- Ropinirole was also shown to significantly reduce periodic limb movements of sleep
(PLMS).
In clinical trials, the most commonly observed adverse events for Adartrel versus placebo were nausea (38 percent versus 8 percent), somnolence (12 percent versus 7 percent), vomiting (13 percent versus 2 percent) and dizziness (12 percent versus 5 percent). Occurrences of nausea were generally mild to moderate in intensity, the release stated.
BY OUR PHARMA CORRESPONDENT |
