22 Mar 2011
The European Medicines Agency (EMA) has decided not to approve sodium oxybate (brand name Xyrem) as a treatment for fibromyalgia.Xyrem is an oral solution that is currently used to treat some cases of the sleep disorder narcolepsy in adults.
However, the EMA's Committee for Medicinal Products for Human Use (CHMP) has made the decision not to recommend it for patients with fibromyalgia, a chronic condition that can cause widespread muscle pain. The drug is classed as a controlled substance in the US because of its potential for abuse.
It is thought that as many as one in every 50 people may suffer from fibromyalgia, but there is currently no approved medication for the long-term condition in Europe.
Professor Iris Loew-Friedrich, chief medical officer at pharmaceutical firm UCB, commented: "Upon discussions and following oral explanation with the CHMP, we have to accept that Xyrem in fibromyalgia syndrome will not be recommended for approval in the EU near-term.
"We are very disappointed with the CHMP decision given the significant unmet medical need in fibromyalgia syndrome in Europe today and the consistently positive phase-III clinical trials with Xyrem in the indication."
The decision comes after results from a second phase-III clinical trial of Xyrem in patients with fibromyalgia were presented at the annual meeting of the American Academy of Pain Medicine.
Results from the trial, which involved 376 patients at more than 100 centres in the US and Europe, showed that 51.4 per cent of patients who took 6g per night and 42 per cent of patients who took 4.5g per night benefited from at least a 30 per cent reduction in pain.
In contrast, just 26.8 per cent of patients who took a placebo (dummy treatment) experienced similar levels of pain relief.
A spokesman for Arthritis Research UK commented that there were few effective drugs available to treat fibromyalgia but added that regulators had to be sure that any new drugs were both effective and appropriate.