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Despite GHB being a popular date rape drug, the US Food and Drug Administration has revealed it believes it to be effective in treating fibromyalgia, say documents released ahead of today’s marketing review.
Jazz Pharmaceuticals is seeking to market gamma hydroxybutyrate under the brand name Rekinla as a treatment for the pain disorder fibromyalgia. According to clinical studies, Jazz claims the drug, which is a powerful nervous system depressant, is also effective at reducing fibromyalgia pain.
However, the documents also cite continual concerns over the safety of the drug, which has been linked to numerous incidents where victims have had their drinks spiked.
GHB though is already available on the market under the brand name Xyrem as a treatment for narcolepsy. Sold by Jazz, the drug is only available under tight conditions where only registered patients and doctors are allowed access and then it is only sold via a central pharmacy to avoid criminals.
The company has proposed selling Rekinla with similar restrictions, with it being available through just 15 pharmacies in the USA.
Xyrem’s net sales for the second quarter of 2010 saw a 51% increase from $22.4 million for the same period last year to $33.7 million.