Xyrem
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This article describes the status of Xyrem as a prescription drug. To learn about the chemical and its biological mode of action, see the article on gamma-hydroxybutyric acid.
Xyrem is a trade name for gamma-hydroxybutyric acid or GHB, an endogenous neurochemical involved in regulating metabolism, especially regarding sleep or hibernation.[1] In medical contexts GHB is often called sodium oxybate, which is an alternate term for the sodium salt of the chemical.
GHB has a long history as a sleep aid, nutritional supplement, and recreational drug. In the 1980s research studies indicated that it was helpful as a treatment for narcolepsy,[2] and in 2002 the company Orphan Medical was approved by the FDA to market GHB as a treatment for narcolepsy with cataplexy.[3] They are currently seeking approval to prescribe it for fibromyalgia as well, based on clinical trials showing that it reduces pain and disability associated with the disease.[4] Xyrem is currently marketed by Jazz Pharmaceuticals, a subsidiary of Orphan Medical.
Xyrem is an orphan drug, meaning that the U.S. government recognizes it as worth developing even though the condition it treats is relatively rare. Orphan Medical received special incentives from the U.S. government for bringing it to market, in order to help them recoup the costs of testing. In this case Orphan Medical did not have any development expenses, since GHB is inexpensive to synthesize and was already recognized as a potential narcolepsy treatment. They did, however, need to gather extensive information demonstrating that the drug was safe, as well as showing low potential for addiction or tolerance when used under a doctor's supervision.
Xyrem is also the only drug to be on two drug schedules at once under U.S. law: GHB is on schedule I, meaning that it is considered a highly dangerous and addictive drug with no medical uses, but GHB marketed as Xyrem and prescribed for specific conditions is on schedule III, which includes many drugs considered relatively safe. This is unusual because the schedule system is built around the assumption that a drug's risks are due to the chemical itself, without reference to the user or the circumstances of its use. However, there are pragmatic reasons for the distinction: recreational drugs are often of unknown origin, may contain contaminants, and are difficult to take at a precise does, while the same substance in prescription form is easier to use as intended. The involvement of a doctor also helps reduce the risk of abuse.
