Despite GHB being a popular date rape drug, the US Food andDrug Administration has revealed it believes it to be effective in treatingfibromyalgia, say documents released ahead of today’s marketing review.
Jazz Pharmaceuticals is seeking to market gammahydroxybutyrate under the brand name Rekinla as a treatment for the paindisorder fibromyalgia. According to clinical studies, Jazz claims the drug,which is a powerful nervous system depressant, is also effective at reducingfibromyalgia pain.
Later today, an FDA panel will consider the drug’sapplication for marketing approval.
According to documents released ahead of the review, the FDAbelieves the drug has proved to be effective in treating the pain condition. Asa reflection of this news, the company’s share price rose.
However, the documents also cite continual concerns over thesafety of the drug, which has been linked to numerous incidents where victimshave had their drinks spiked.
GHB though is already available on the market under thebrand name Xyrem as a treatment for narcolepsy. Sold by Jazz, the drug is onlyavailable under tight conditions where only registered patients and doctors areallowed access and then it is only sold via a central pharmacy to avoidcriminals.
The company has proposed selling Rekinla with similarrestrictions, with it being available through just 15 pharmacies in theUSA.
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.
