F.D.A. Approves Xywav, a GHB drug, for Uncommon Sleeping Dysfunction
Homemade GHB – also known as Liquid Ecstasy, Goop, and G – can be bought on the black market for $ 5 to $ 25 per capful. But nightly treatments from Xyrem and Xywav cost about $ 100,000 a year. The new approval will make it much easier for hypersomnia patients to get coverage for Xywav.
Many doctors and patients have never heard of idiopathic hypersomnia, Cozadd said, but Jazz will try to change that. “We will take part in an educational work,” he said, “which really ensures that practitioners and patients better understand the disease and its treatment.”
The FDA said its decision was significant as it will be the first drug approved for the treatment of the condition.
“Idiopathic hypersomnia is a lifelong condition and the approval of Xywav will be instrumental in managing symptoms such as excessive sleepiness and difficulty waking up and in effectively treating this debilitating disorder,” said Dr. Eric Bastings, deputy director of the Neuroscience Agency’s office, in a statement.
In March, Jazz and the Hypersomnia Foundation, a patient advocacy group, launched an awareness campaign – “I have IH” – which included an online survey of healthcare providers’ knowledge of the condition (it was low) and advertisements in Times Square.
“I never thought I’d live to see that day – it was very emotional,” said Betsy Ashcraft, the foundation’s treasurer, whose adult son suffers from idiopathic hypersomnia. (Jazz paid the foundation for board members’ counseling time on the campaign, she said.)
GHB is an ancient drug that was first synthesized by a Russian chemist in 1874. A century later, it was sold as a dietary supplement in the United States, and academic researchers reported that it greatly improved nighttime sleep for people with narcolepsy and their daytime attacks of paralysis called cataplexy.