experts however, are wary of the decision, the new york times reports, with some arguing that the supporting publicly available evidence is weak and raised concerns around the danger of using the medication.
“for some years i’ve had questions about whether this drug has benefits that exceed its high risks,” said thomas moore, a researcher at the center for drug safety and effectiveness at johns hopkins university. in 2014 moore published a report that urged the fda to re-evaluate xyrem.
now branded as xywav, but better known as gamma-hydroxybutyrate (ghb), the drug is believed to provide restorative sleep for some patients at night. however xywav, and an older higher-salt iteration named xyrem, come with a number of side effects, such as anxiety, depression, sleepwalking, hallucinations and suicidal thoughts. xywav is so fast-acting, that its’ label advises patients to use the medication while in bed.
gamma-hydroxybutyrate (ghb) used to be prescribed to women during childbirth in the 1960s to dull consciousness. by the 1990s, ghb was linked to dozens of deaths and sexual assaults, gaining a reputation as a “date rape” drug. today, the drug can be bought on the black market, often priced between $5 and 25 usd and is commonly known as liquid ecstasy, goop and g.
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in 2000, subsequent to ghb being linked to sexual assault and deaths, the u.s. congress passed a law making the drug illegal with exemptions in place for future medical uses.
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the approval is based on a clinical trial with 154 adult patients between the ages of 19-75, reported u.s. news . patients that were switched off of xywav to a placebo experienced more severe symptoms of idiopathic hypersomnia when compared to individuals who continued taking the drug, according to the fda.
dublin-based jazz pharmaceuticals, which acquired orphan medical in 2005, made over$1.7 billion usd last year selling xyrem and xywav, reported new york times. bruce cozadd, the chairman and chief executive of the company announced the approval thursday.