Jazz Pharmaceuticals (NSDQ:JAZZ) has announced that its Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution has won FDA approval for treating idiopathic hypersomnia in adults.
Idiopathic hypersomnia is a rare chronic disorder involving chronic excessive daytime sleepiness.
Previously, the drug was FDA approved for treating cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.
FDA first approved a related drug, Xyrem (sodium oxybate), for narcolepsy in 2002. At that point, Orphan Medical was its manufacturer. Jazz Pharmaceuticals acquired that company in 2005.
Xywav is a revised version of Xyrem.
As the drug is a central nervous system depressant, Jazz plans to make the drug available to patients with idiopathic hypersomnia later in 2021 after performing a Risk Evaluation and Mitigation Strategies (REMS) implementation.
The drug will be available as part of a restrictive program intended to prevent abuse.
In 2007, Jazz paid a $20 million fine for Orphan Medical’s prior off-label marketing of the related drug, Xyrem (sodium oxybate).
In the second quarter of 2021, sales of Xyrem and Xywav were $458 million.
“We are excited that with today’s approval, Xywav will become the first and only medicine indicated to treat idiopathic hypersomnia, a unique medical condition that can have significant effects on the lives of those diagnosed with the condition,” said Bruce Cozadd, Jazz Pharmaceuticals CEO, in a statement.
FDA based its approval decision on a Phase 3 double-blind, multicenter, placebo-controlled, randomized trial.
FDA indicated the drug as a twice- or once-nightly therapy for idiopathic hypersomnia in adults.
Correction: This article previously did not specify that the $20 million fine for off-label marketing of Xyrem related to marketing activities Orphan Medical performed before Jazz Pharmaceuticals acquired the company.
Filed Under: clinical trials, Neurological Disease