The FDA Has Approved a Controversial Drug to Treat Idiopathic Hypersomnia

 

A recent headline in the New York Times called out that therapy sometimes dubbed the “date rape” drug had just been approved by the FDA to treat a rare sleeping disorder.

The history of Gamma-hydroxybutyrate (GHB) dates back to 1874 when it was synthesized by a chemist in Russia.

One hundred years later, in the U.S., it was recommended as a supplement for dietary purposes. Women were administered GHB in the 1960s to lessen their degree of consciousness during childbirth.

In 1994 researchers began recommending GHB for improving sleep problems such as narcolepsy. The FDA suggested Orphan Medical investigate GHB offering incentives for the successful development of the drug. These incentives, such as seven years of marketing exclusivity and tax credits, are granted for the development of drugs that face limited patient markets.

The drug also appeared to have a positive effect on cataplexy (paralysis). But during the 1990s an illicit form of the drug was found to be responsible for many sexual assaults and deaths.

GHB has been strictly regulated for the past two decades to treat narcolepsy, a disorder causing unexpected sleepiness.

Fast forward to 2021 and we find that GHB has the FDA’s approval to treat a disorder called idiopathic hypersomnia. The disease is estimated to affect approximately 40,000 people in the U.S. People who have the disease tend to sleep over nine hours without feeling rested. The other name for the drug developed by Jazz Pharmaceuticals of Dublin is Xywav, and it is the first approved treatment for the disorder.

It is believed that Xywav provides restorative sleep that allows the patients’ brains to be fully alert during the day.

When In Doubt

A high-salt form of Xywav called Xyrem and Xywav itself have caused serious adverse advents such as suicidal thoughts, depression, sleepwalking, anxiety, and hallucinations.

According to Dr. Lewis Nelson, Rutgers’ medical toxicology director, the drug has several safety concerns, including addiction. Dr. Nelson predicts that now that the drug has received approval, more people experiencing daytime drowsiness will receive an idiopathic hypersomnia diagnosis, especially since its symptoms overlap with so many other conditions. The latest approval will no doubt facilitate insurance coverage for Xywav in the treatment of hypersomnia patients.

Homemade GHB

About the same time, just as a patient advocacy group and Jazz Pharmaceutical began an awareness campaign in favor of the drug, an illicit market for GHB arose. Within that market, GHB was called liquid ecstasy, G or goop. The drug brings about $5 to $25 per capful. However, nightly doses of Xyrem and Xyway costs about $100,000 annually.

When used at low doses, the drug triggers sexual arousal and euphoria. If a person uses it at a high dosage especially when mixed with alcohol, the drug is capable of rendering a person unconscious with no recollection of what happened.

An Illegal Drug

Following its link to deaths and sexual assaults, a law passed by Congress rendered GHB illegal but made an allowance for medical uses in the future. In the same year, Orphan Medical applied to the FDA for approval of Xyrem to treat narcolepsy.

Conflicting testimonies with respect to GHB took place at the FDA advisory committee meeting. A lawyer testified that he has been taking GHB for nineteen years to treat narcolepsy. He said his cataplexy cleared up almost immediately with no side effects.

On the other hand, a woman testified at the meeting that her daughter used GHB to enhance her bodybuilding and was subsequently addicted. She said she came to the meeting to tell people that GHB killed her daughter.

The meeting culminated with the FDA approving Xyrem to treat narcolepsy with cataplexy in 2002.

Adverse Events

Adverse Events are defined as those side effects that are life-threatening, lead to hospitalization, medical conditions, and death. The FDA recorded 27,000 adverse events for patients who had taken Xyrem or Xywav. This included 753 deaths. The FDA notes that these numbers may be incomplete or inaccurate because some events occurred to people who took multiple drugs and there are no reports to substantiate the data.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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