Sodium oxybate to garner over 15% of the fibromyalgia drug market despite safety concerns

Jan 18 2010

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, despite potential safety concerns, Jazz Pharmaceuticals/UCB's sodium oxybate (JZP-6) will account for more than 15 percent of the fibromyalgia drug market in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Sodium oxybate has demonstrated robust efficacy in Phase III clinical trials for fibromyalgia and interviewed thought leaders are impressed with its effect on several key symptom domains of fibromyalgia, which include pain, sleep and fatigue.

However, sodium oxybate's risk for severe adverse events and abuse/illicit use, as well as its high price and inconvenient dosing are expected to substantially limit its uptake and will relegate the agent's use to only a niche market within fibromyalgia: patients who have failed multiple other therapies and are under the care of a specialist. Owing to its drawbacks, sodium oxybate is only expected to garner a patient share of approximately five percent in the world's major pharmaceutical markets.  

"Although factors such as safety, abuse potential and risk of illicit use will ultimately constrain its overall market potential, sodium oxybate's expected premium price will translate into robust sales," said Decision Resources Analyst Andrea Buurma, B.A. "We expect sodium oxybate will be prescribed primarily by specialists to patients with the most severe fibromyalgia who are unresponsive to or cannot tolerate other medications."

In December 2009, Jazz Pharmaceuticals submitted an application for regulatory approval of sodium oxybate for the treatment of fibromyalgia and Decision Resources expects the drug will be approved for this condition in mid-2010.

The Pharmacor finding from the topic entitled Fibromyalgia also reveals that the recent U.S. patent extension that was granted for Sepracor's Lunesta (eszopiclone) has increased the forecast for Lunesta to account for the later than previously expected market entry of generic eszopiclone. As a result, Lunesta will earn U.S. sales of nearly $34 million in the fibromyalgia market in 2013.