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news.The FDA has given its approval for Jazz Pharmaceuticals to market its Xyrem oral solution in an expanded indication to treat excessive daytime sleepiness in patients with narcolepsy.
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Xyrem was approved by the FDA in October 2002 as a treatment for cataplexy (sudden inability to move) in patients with narcolepsy.
The effectiveness of Xyrem for the treatment of narcolepsy symptoms was established in four placebo-controlled trials, studied over a period of time between four and eight weeks. The studies examined three dosages of the drug taken in two equally divided doses, the first at bedtime and the second 2.5 to four hours later.
Two clinical trials demonstrated that the drug at doses of 6g and 9g per night is effective at substantially improving excessive daytime sleepiness.
Furthermore, patients on the 6g or 9g per night doses saw significant improvements in quality of life, with the majority of them rating much or very much improved on the clinical global impression of change in day and nighttime symptoms scale.
“We are very pleased that the data from these studies show nightly Xyrem therapy reduces excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy,” said Dr Phil Perera, chief medical officer of Jazz Pharmaceuticals.