Jazz Pharmaceuticals Drug Rejected By FDA Panel – The FDA has rejected a drug from Jazz Pharmaceuticals that would potentially help people with a pain condition like fibromyalgia. The FDA panel voted 20-2 against approving the drug, and said that the drug just presented too much of a risk. They wanted to market sodium oxybate as a potential fibromyalgia treatment. Jazz already markets the drug as a treatment for excessive sleepiness under the brand name Xyrem.
The drug is currently a controlled substance, and the FDA did not want to expand the usage of the drug. The active ingredient has been used as an illegal stimulate and a date rape drug. Access to the drug is limited and doctors must register with the government before prescribing the drug to patients.
It is clear that they were not ready to expand the use of the drug that has caused damage in the past. Between 6 and 12 million people in the US suffer from fibromyalgia, and more than 80 percent of those with the condition are women, according to the American College of Rheumatology.
Jazz said that they would distribute the drug through 15 specialty pharmacies if the drug were expanded for further use. Jazz was going to market the drug under the name Rekinla. It will be interesting to see if the company continues to pursue making the drug more available. It does not appear that the FDA is willing to cooperate with this effort.