Posted by utopizen on April 24, 2003, at 16:52:56
http://talkaboutsleep.com/News_03/Orphan_Reiterates2002.htm
t update
Orphan Medical announced that it expects to complete by mid-2003 its currently active Phase III(b) trial to evaluate Xyrem as adjunctive treatment for excessive daytime sleepiness (EDS) in narcolepsy. This trial is designed to determine if EDS is further improved when Xyrem is used with the stimulants most often used to treat EDS.The Company also described other development activities that have been initiated or will be initiated in 2003. Patient enrollment for these trials is planned to begin in the second half of 2003.
The EXCEEDS (Evaluation of Xyrem to Check Efficacy in Excessive Daytime Sleepiness) trial is a second Phase III(b) clinical study to assess the effects of Xyrem on EDS with and without stimulants. The data from both EDS trials will be included in a supplemental NDA expected to be submitted in the first half of 2004.
Orphan Medical stated that it has begun development of a new patent-protected formulation of Xyrem. The Company is evaluating formulation alternatives that could extend the activity of a single Xyrem dose from the current two-four hour range to a six-eight hour range.
During 2003, the Company expects to begin a proof-of-principle study to evaluate Xyrem for symptomatic treatment of Fibromyalgia Syndrome (FMS), a chronic condition that is estimated to affect as many as six million individuals in the United States. Fibromyalgia Syndrome is characterized by widespread pain in joints, muscles, tendons, and other soft tissues. Other symptoms include persistent fatigue, headaches, cognitive or memory impairment, morning stiffness and non-restorative sleep. The cause of fibromyalgia is unknown, although an imbalance in growth hormone production may play a role. Studies have demonstrated improvement in symptoms in FMS patients given growth hormone. In addition to increasing restorative sleep, Xyrem may be a growth hormone secretogogue and may therefore produce symptomatic relief. The Company does not expect results from this proof-of-principle FMS study until the second half of 2004.
poster:utopizen
thread:222062
URL: http://www.dr-bob.org/babble/20030423/msgs/222062.html