SILVER SPRING, Md. A drug used to treat narcolepsy soon could win approval to treat the chronic pain condition fibromyalgia, thanks to a favorable review by two Food and Drug Administration advisory committees, FDA documents showed.
The agency’s advisory committees for arthritis drugs and drug safety and risk management said that it appeared Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution was an effective treatment for the condition, which affects 3 million to 6 million people in the United States.
“Sodium oxybate offers an important new therapeutic option for these patients, providing substantial benefits across multiple symptom domains,” the reviewers wrote.
Still, they had concerns about the potential for abuse of the drug, which is already a Schedule III controlled substance. The drug is a sodium salt of gamma-hydroxybutyrate, or GHB, a commonly abused drug that carries risks of dangerous and sometimes fatal side effects.