Boehringer Ingelheim’s Sifrol/Mirapexin has become the first treatment for restless legs syndrome (RLS) to be approved throughout the European Union.
Boehrimger said in a statement that Sifrol (pramipexole) has been shown to provide clinically significant relief from the broad range of symptoms associated with RLS. Until now, there have been few treatment options available to alleviate the symptoms of RLS, which can significantly impact patients’ quality of life.
Millions of people throughout Europe are thought to be affected by this debilitating neurological movement disorder, which is characterised by an uncontrollable urge to move the legs and painful or distressing sensations in the lower limbs
In RLS, pramipexole is going head to head to with another drug in the dopamine agonist class, GlaxoSmithKline's ReQuip (ropinirole), which was recommended for approval in Europe in September 2005 and launched for that indication in the USA the previous June.
In Europe, Spain and the Netherlands raised concerns over the safety and efficacy for ReQuip in RLS, though it was approved in France - as Adartrel - in December 2004.