GlaxoSmithKline’s drug for the neurological condition restless legs syndrome, Adartrel, has been recommended for approval in the European Union, setting the stage for its full approval in May.

If approved, Adartrel (ropinirole) will compete with Boehringer Ingelheim’s just-approved Sifrol/Mirapexin (pramipexole), which was cleared throughout the EU last week.

The positive opinion on Adartrel from the EU’s Committee for Medicinal Products for Human Use comes some months after Adartrel was first approved for restless legs syndrome in France at the end of 2004. It is already on the market in France and Switzerland.

Pan-European approval of the drug was expected to occur via the mutual recognition procedure, but Spain and the Netherlands raised questions about the application, particularly the efficacy and long-term safety of the drug, and the application was referred to the CHMP.

Millions of people throughout Europe are thought to be affected by this debilitating neurological movement disorder, which was first described in the early 1940s by eminent neurologist Karl Ekbom. RLS is characterised by a compelling urge to move the legs and by uncomfortable or sometimes painful sensations in the legs often described as creeping-crawling, tingling, pulling or tightening.

Both Adartrel and Sifrol are dopamine agonists already used in the treatment of Parkinson’s disease, and are thought to exert their effects in restless legs syndrome by addressing an abnormality in the central dopamine system in the brain.

Ropinirole was approved for restless legs syndrome in the USA in May 2005, becoming the first drug to get the nod for the condition there. The new indication expanded US sales of the drug, where it is sold as ReQuip, threefold in the quarter after launch on the back of pent-up demand from restless legs sufferers. It is also sold in Australia under the Repreve brandname.

- Meanwhile, GSK has dismissed as 'irresponsible' allegations in Forbes magazine that its combination asthma drug Advair (salmeterol and fluticasone) could be responsible for the deaths of 4,000 people in the USA a year. The article cites Stanford University academic Shelly Salpeter as saying the £3 billion drug should be recalled. Labelling for Advair was recently tightened to limit its use.