Safety And Efficacy Of Xyrem Oral Solution Essay

766 WordsDec 10, 20154 Pages
The first clinical trial for Xyrem, titled Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients was conducted by Orphan Medical. The study began in December 2000 with approximately 200 people enrolled. The purpose was to test the safety and efficacy of Xyrem when given to patients who are diagnosed with narcolepsy. The patients who were using any medication for cataplexy had to stop taking it during this trial. Patients were prescribed a dose oral solution of either Xyrem or a placebo during a 10 to 11 week period. Symptoms of narcolepsy will be recorded and evaluated. Patients had permission to continually use the medications at constant doses during the trial. Each patient had to visit the sleep center for 1 to 3 daytime visits plus 4 overnight visits to complete the trial. This trial was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. An NDA (New Drug Application) was sent to the FDA during the same year of this clinical trial. It was given a priority review, where the FDA will accelerate the review process for a drug compared to standard review times. In 2005, Orphan Medical was bought by Jazz Pharmaceuticals. However, before and after the buy out various clinical trials were being conducted to test for Xyrem’s efficacy in treating narcoleptic symptoms like cataplexy and excessive daytime sleepiness (EDS). Two clinical trials looked at cataplexy in narcolepsy while two other
Open Document