Narcolepsy Rx Gets Green Light

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new treatment option for narcolepsy.

This new approval is found under the name Xywav (calcium, magnesium, potassium and sodium oxybates). The FDA approved it for adults and children starting at 7 years old.

Specifically, this medication is approved to treat cataplexy or excessive daytime sleepiness associated with narcolepsy. Cataplexy is a brief, sudden loss of voluntary muscle tone.

This medication, from Jazz Pharmaceuticals, is available in solution form to be taken by mouth.

This new treatment option is a lower-sodium alternative to Xyrem (sodium oxybate), which is also made by Jazz Pharmaceuticals. In fact, this newer option contains 92 percent less sodium than Xyrem.

“This may help patients taking sodium oxybate better align with daily sodium intake recommendations including those by the American Heart Association,” said Dr. Richard K. Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine and lead investigator of a phase 3 study of this drug, in a press release.

The approval of Xywav came after two studies (one study in adults and one in children) found the medication to be safe and effective.

Common side effects of Xywav seen in both adults and children included headache, nausea/vomiting, dizziness and decreased appetite. Common side effects seen in adults included anxiety, diarrhea, excessive sweating, and a sleep disorder that can result in night terrors and sleepwalking. In children, common side effects included the inability to control urination.

This medication comes with a boxed warning regarding the potential for misuse and abuse.

This medication is expected to be available at the end of this year.