Xyrem Receives Expanded Indication
October 26, 2018 – The U.S. FDA has approved an expanded indication for Xyrem® (sodium oxybate) oral solution, manufactured by Jazz Pharmaceuticals. Xyrem is now approved to treat cataplexy and excessive daytime sleepiness (EDS) in patients who are seven to 17 years old and have narcolepsy.
Approximately 200,000 people in the United States have narcolepsy. According to the National Sleep Foundation, up to 70% of this population experiences cataplexy, a condition in which strong emotions can trigger sudden, uncontrollable episodes of muscle weakness or paralysis while the individual is fully conscious. The episodes can last for a few minutes at a time, and are associated with a lack of cells in the brain responsible for secreting hypocretin. Without sufficient levels of hypocretin in the brain, the body has difficulty regulating sleep and wakefulness.
Xyrem originally received FDA approval in 2002 to treat adults who have narcolepsy with cataplexy. It can also be used to treat EDS in adults who have narcolepsy. The recommended dosing requires titration from a low starting dose to a maintenance dose at weekly intervals. Each nightly dose is divided in half, with the first half taken at bedtime, and the second half between two-and-a-half to four hours later. Patients should take the medication while in bed, and lie down after.
A central nervous system (CNS) depressant, Xyrem is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. According to its black box warning, Xyrem can cause respiratory depression and is a Schedule III controlled substance. Misuse or abuse of the drug may lead to adverse CNS effects, including respiratory depression, decreased consciousness, coma, and death.