Jazz Pharmaceuticals Reports on Phase III Trial of Fibromyalgia E

Discussion in 'Fibromyalgia Main Forum' started by meowee, Sep 11, 2008.

  1. meowee

    meowee New Member

    Jazz Pharmaceuticals Inc reported that the final patient had completed participation in the first Phase III trial of their drug-in-development JZP-6 (sodium oxybate), for the treatment of fibromyalgia or chronic pain syndrome.
    09-11-2008 | 11:59 hs.Author: Cate Kirby |

    Jazz Pharmaceuticals, based in Palo Alto, California, reported participation in their first Phase III trial with experimental JZP-6, for the treatment of fibromyalgia, has been completed, and it was on track to release study data in the fourth quarter.

    The first study for JZP-6 (sodium oxybate) enrolled 550 fibromyalgia patients at 65 centers in the U.S. A second late-stage study is enrolling patients at sites in the U.S. and Europe.

    Jazz CEO Samuel Saks said the company anticipated releasing primary efficacy and safety data from the first Phase III clinical trial on schedule in the fourth quarter of this year, and planned to submit an NDA to the Food and Drug Administration by the end of 2009.

    Sodium oxybate is also the active ingredient in Jazz´s drug Xyrem, being sold as a treatment for the sleep disorder narcolepsy.

  2. Juloo

    Juloo Member

    That is good news. As a person with a Xyrem prescription, I am very interesting in any information on this topic, and desperately hoping that the study holds good news. Although it is one of the medications that helps me most, I can not afford it at present, as I do not meet the narrow 'narcolepsy with cataplexy' requirements that my insurance company has for paying. It would be a relief if *I* could get some "relief" with paying for it. I put a lot of time and effort getting the dosage right for me, only to have to put treatment on hold.
  3. hensue

    hensue New Member

    Have you been in this trial? i am pretty interested in that to see if it really helps fibro. i have heard people sleep walk and crazy stuff so i am anxous to see if this helps pain?