Based on our Pharmacor advisory service entitled Fibromyalgia, Decision Resources is offering an exclusive analyst call entitled The End of the Line for Jazz Pharmaceuticals’ Fibromyalgia Agent? Assessing the Impact of an FDA Panel’s 20 to 2 Vote Against Sodium Oxybate’s Approval. Because this presentation will feature major updates, it is ONLY available to purchasers of this Pharmacor advisory service.

Jazz Pharmaceuticals’ sodium oxybate (Xyrem), an oral liquid formulation of the Schedule I controlled-substance gamma-hydroxybutyrate (GHB), is currently marketed in the United States for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. The company has also completed two Phase III clinical trials with sodium oxybate for fibromyalgia in the U.S. and Europe, in partnership with UCB—the European marketer of Xyrem. In December 2009, Jazz Pharmaceuticals submitted an application for regulatory approval of sodium oxybate for the treatment of fibromyalgia in the U.S. and, in July 2010, UCB submitted an application for the agent’s approval in Europe.

Last month, an FDA advisory panel consisting of experts from the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee met to consider the approval of sodium oxybate for fibromyalgia in the U.S. Although the committee indicated a degree of satisfaction regarding the efficacy sodium oxybate has demonstrated in clinical trials as well as its potential to serve this difficult-to-treat patient population, the panel ultimately objected to the approval of this agent. In a 20 to 2 vote, an overwhelming majority of panelists ruled that the risk-benefit balance of sodium oxybate did not favor its approval for fibromyalgia at this time.

By October 11, 2010, the FDA is expected to make a final decision regarding sodium oxybate’s application for approval as a treatment for fibromyalgia.

Date & Time
Wednesday, September 15, 2010
10 a.m. U.S. Eastern Time,
4 p.m. Central European Time

This 15-minute analyst call, presented by Decision Resources Analyst Andrea Buurma will answer the following questions:

• What were the panel’s concerns regarding sodium oxybate’s approval for fibromyalgia and how is their negative opinion expected to impact the FDA’s final decision?
• If the FDA fails to grant sodium oxybate’s approval for fibromyalgia, how will this affect the overall fibromyalgia drug market through 2019?
• Which drug(s) would benefit from a failure of sodium oxybate to launch?
• Could sodium oxybate reach the fibromyalgia market during our forecast period and, if so, what is its market outlook?
   

Contact us to learn how you can purchase this service and attend this event.

Click here to view the invite.