oxybate

Sodium oxybate, which is currently approved for narcolepsy-associated cataplexy and excessive daytime sleepiness, is a potent central nervous system depressant.

MedPageToday.com - medical news plus CME for physicians 2010

Sodium oxybate, which is currently approved for narcolepsy-associated cataplexy and excessive daytime sleepiness, is a potent central nervous system depressant.

MedPageToday.com - medical news plus CME for physicians 2010

JZP-6, or sodium oxybate, is a form of the central nervous system depressant GHB, a known drug of abuse.

Jazz Buy Is to the Tune of $522,225 2010

Xyrem is known by its generic name, sodium oxybate.

FDA Raises Concerns 2010

Jazz Pharmaceuticals markets sodium oxybate in another form as Xyrem under a restricted distribution system to between 10,000 and 12,000 people as a treatment for narcolepsy, a condition marked by excessive daytime sleepiness.

Jazz Buy Is to the Tune of $522,225 2010

The agency said the data wasn't strong enough to show that sodium oxybate improved sleep.

FDA Raises Concerns 2010

In an illegal form, sodium oxybate is known as the street drug GHB.

FDA Raises Concerns 2010

Sodium oxybate is sold as part of a controlled distribution system through a central pharmacy that was designed to limit abuse and misuse of the product.

FDA Raises Concerns 2010

However, the agency said clinical data submitted by Jazz suggests sodium oxybate is effective at reducing fibromyalgia pain.

FDA Raises Concerns 2010

The FDA has asked the panel to vote on whether it thinks sodium oxybate should be approved to treat fibromyalgia.

FDA Raises Concerns 2010