EU regulator rejects Xyrem as fibromyalgia treatment

 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.

http://www.arthritisresearchuk.org/about_us/arthritis_news/articles/eu_regulator_rejects_xyrem_as.aspx

European Medicines Agency decided against Xyrem (sodium oxybate)

Adrienne Dellwo, March 21, 2011
The European Medicines Agency has decided against recommending Xyrem (sodium oxybate) for treating fibromyalgia in adults. To date, the European Union doesn't have any medications approved for fibromyalgia.
Xyrem is approved in both the EU and the U.S. for narcolepsy and cataplexy (a narcolepsy symptom.) The U.S. FDA rejected this medication as a fibromyalgia treatment in October 2010, citing concerns over safety because it's similar to the date-rape drug GHB.
In clinical trials, Xyrem has been shown to improve the quality of stage-four sleep in fibromyalgia. Disrupted deep sleep is believed to be a primary contributor to symptoms of this illness and may play a role in its pathogenesis.
http://chronicfatigue.about.com/b/2011/03/21/eu-says-no-to-proposed-fibromyalgia-drug.htm

Jazz Pharmaceuticals Inc. Reports Operating Results (10-K)

We have a number of product candidates in various stages of clinical development. In 2010, 2009 and 2008 we spent $25.6 million, $36.6 million and $70.0 million, respectively, on research and development activities.

UCB has the right to market JZP-6 for the treatment of fibromyalgia in 54 countries outside the United States. UCB has submitted an application to the European Medicines Agency for approval to market and promote JZP-6, and if it is approved, we are entitled to a milestone payment of up to $25 million, royalties on UCB’s sales of JZP-6 and additional commercial milestone payments of up to $100 million. No product has been approved in Europe for the treatment of fibromyalgia. The term of our agreement with UCB, as it applies to JZP-6, extends to the later of the expiration of our associated patent rights in the territories covered by the agreement or ten years from the date of EMA approval to commercially promote and distribute the product for the treatment of fibromyalgia, subject to automatic extension unless UCB provides 12 months’ notice. UCB may terminate our agreement for any reason upon 12 months’ notice and may terminate its rights to JZP-6 for the treatment of fibromyalgia on six months’ notice at any time prior to the receipt of marketing approval of JZP-6 for fibromyalgia in the European Union. We are responsible for supplying JZP-6 to UCB in exchange for supply price payments.

http://www.gurufocus.com/news.php?id=125144