Date Rape Drug May Help Patients With Fibromyalgia?
Just a quick post on an article that caught my eye: Jazz Pharmaceuticals of Palo Alto, CA, has announced that the US FDA has accepted their new drug application (NDA) filing for JZP-6, or sodium oxybate, for the treatment of pain and fatigue associated with fibromyalgia.
The NDA was based on positive outcomes of two, Phase III clinical trials – those randomized, placebo-controlled double-blind trials that serve as the gold standard for drug efficacy. The company expects an approval decision from FDA by October 2010.
Jazz has already garnered approval for sodium oxybate under the brand name Xyrem® for the treatment of daytime sleepiness in patients with narcolepsy. The company stresses, however, that the drug has not yet been approved for symptoms associated with fibromyalgia.
The item of note here is that sodium oxybate is another name for the sodium salt of gamma-hydroxybutyrate or GHB, a sedative that resembles the inhibitory neurotransmitter GABA but also has its own receptors in the central nervous system. GHB was implicated as far back as the early 1990s on college campuses where young men who lacked any other redeeming qualities to attract women used it to dope the drinks of their dates.
But here we see the study of a drug of abuse giving rise to a useful pharmaceutical, first in narcolepsy and, soon perhaps, for fibromyalgia.
It is a paradox of pharmacology that a sedative like GHB would prevent excessive sleepiness or fatigue. But a similar paradox exists with the use of the stimulant methylphenidate in hyperactivity conditions.
Now that I’ve seen the business reports, I’ll turn to some of my CNS pharmacology colleagues to help explain the neurobiology.
However, this compound demonstrates to me the unanticipated benefits of funding research that aims to investigate drugs of abuse.
Beneficial therapeutic agents come when and where you may least expect them.
*This blog post was originally published at Terra Sigillata*
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