=FDA approves first generic version of Jazz Pharmaceuticals' Xyrem

FDA approves first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease


Jazz Pharmaceuticals PLC (JAZZ) faced public ire last year for its substantial price hikes for its sleep disorder drug Xyrem (sodium oxybate), but the cash cow drug is now facing challenges from generic drugs.

The U.S. Food And Drug Administration (FDA) has approved the generic version of Xyrem, which was developed by Roxane Laboratories Inc., a part of the West-Ward Pharmaceuticals family.

Xyrem is used to treat narcolepsy, a sleeping disorder which leads to uncontrollable daytime sleepiness and drowsiness. It is also approved for treating the cataplexy condition occurring in narcolepsy patients, which is a chronic neurological disorder involving sudden and transient episode of muscle weakness and loss of physical control.

More than 70% of narcolepsy patients suffer from cataplexy complexity. Sodium oxybate is the only medication approved to treat cataplexy in patients with narcolepsy.