Orphan wide awake with SXB-15
Orphan Medical has received strong positive data across both primary and secondary endpoints from its Phase III(b) clinical trial known as SXB-15.
Orphan Medical has received strong positive data across both primary and secondary endpoints from its Phase III(b) clinical trial known as SXB-15.
The trial evaluated improvement in the excessive daytime sleepiness (EDS) of patients with narcolepsy when a dose of 4.5, 6.0 or 9.0g of Xyrem (sodium oxybate) oral solution was added to the unchanged stimulant therapy. This double-blind, placebo-controlled, randomised trial assessed 228 patients over an eight week treatment period in 40 sleep centres in North America and eight in Europe.
Narcolepsy is a chronic, debilitating neurological disease characterised by symptoms of excessive day-time sleepiness, cataplexy (sudden loss of muscle tone) and fragmented night time sleep. Excessive daytime sleepiness is experienced by all narcolepsy patients and is usually treated with stimulants during the day to help keep patients awake. Xyrem is currently the only approved medication for the treatment of cataplexy.
Dr Bill Houghton, chief medical & scientific officer, Orphan Medical, said: 'This was a positive trial across all measures. The results are all the more striking given that Xyrem was used in addition to stimulants commonly prescribed to treat EDS. We are very pleased with the results of this trial and look forward to analysing the data further over the next few weeks.'