Why Xyrem has been Rejected as a Treatment for Fibromyalgia

This past week, the FDA rejected Xyrem (sodium oxybate) as a treatment for fibromyalgia. Why? The reason for the rejection is that sodium oxybate is very similar chemically to GHB, the “date rape” drug.

Experts worry that approving Xyrem for the millions of people suffering from fibromyalgia would inundate the streets with a drug that has the potential for abuse and harm. At this time, the drug has only been approved for narcolepsy, a condition which causes people to fall deeply asleep suddenly and unexpectedly. About 35,000 people have been prescribed the drug since 2002 for treatment of narcolepsy.

Jazz Pharmaceuticals, the maker of Xyrem, sought approval to use Xyrem for the treatment of fibromyalgia, specifically to address sleep and pain issues. The FDA reviewed studies that showed that Xyrem effectively treated symptoms of pain, but evidence was not convincing that the drug was effective for the treatment of sleep disorders in fibromyalgia, according to the FDA panelists.

Patients who took part in trials to test the effectiveness of the drug for fibromyalgia symptoms argued passionately that the drug should be approved, as they found the drug more effective than the three other drugs currently approved to treat symptoms of fibromyalgia, namely Savella, Cymbalta and Lyrica. It has been estimated that approximately half of patients do not respond as predicted to these drugs approved by the FDA for the treatment of fibromyalgia.

The FDA panelists who refused to approve the drug cited concerns about the company’s ability to safeguard the drug and manage potential risks. The panelists saw no other option but to block approval of the drug, absent any real ability to prevent misuse of the drug.
It is unfortunate that a drug which shows great promise in treating fibromyalgia pain should be a drug with such a high potential for abuse.