Promising Fibromyalgia Drug Blocked by FDA

Posted by Ginevra Liptan, MD

It’s disappointing to start this blog off with some bad news, but we just learned this week that the Food and Drug Administration did not approve the drug Xyrem (sodium oxybate) for use in fibromyalgia. This sleep medication is currently only approved for use in narcolepsy, a rare sleep condition. Xyrem is quite expensive (we’re talking around $20,000 a year) and without FDA approval for use in fibromyalgia, it is unlikely that insurance companies will pay for it.

Xyrem is a strong sedative medicine that induces deep sleep, the stage of sleep that is lacking in people with fibromyalgia. Yes, it is related to the “date-rape drug” GHB (gamma-hydroxybutyrate) that has been abused as a party drug and used in high doses along with alcohol to induce sedation. When used medicinally, in low doses, it has been shown to be very safe. But the risk for diversion and abuse is primarily what’s behind the FDA’s decision, as they feel there is not enough evidence for the benefits outweighing the risks.

I beg to differ, and it is really frustrating to me that most of my patients now won’t even be able to try this medication. I have been impressed with the results for the few patients I have been able to prescribe Xyrem. When I called to check in with one of my patients recently who has been on the drug for about 4 months now, she said she was feeling “not perfect, but so much better.” And that she was going camping with her grandkids that weekend! Anyone with fibromyalgia knows what a big deal that is.

Four studies have looked at Xyrem in fibromyalgia, and all four have shown improvement in sleep patterns, fatigue and pain. At the start of one study, the average fibromyalgia subject experienced 15% deep sleep (as a percentage of total sleep time). After using the medication nightly for one month, the sleep study was repeated and this time the percentage of deep sleep had increased to 22% (a normal, healthy amount). A European study found that two-thirds of the fibromyalgia subjects taking this medication experienced a significant reduction in pain and fatigue. These studies show much more improvement in symptoms, particularly with fatigue, than any of the currently approved medications for fibromyalgia.

I’m currently finishing a book on fibromyalgia, and in it I detail the crucial role that treating deep sleep plays in improving symptoms. I can appreciate the FDA’s safety concerns, given the association with a drug that has been abused in the past. But under the supervision of a physician, and in the proper dosage, Xyrem has real potential to help people get better.

Jazz Pharmaceuticals, the company that owns Xyrem, may not be willing to invest millions of dollars in further research required by the FDA, and may give up on trying to get approval for use in fibromyalgia. I hope the fibromyalgia patient community will be able to convince them—and the FDA—otherwise.

3 thoughts on “Promising Fibromyalgia Drug Blocked by FDA

  1. Pingback: GHB and Alcoholism: I’ll (Not) Drink To That « Thought Broadcast

  2. I was one of the investigators for the Xyrem studies and it was clearly far superior to the studies we did for Lyrica, Milnacipran and Cymbalta. While those studies often reported average reduction in the VAS score to 3’s and 4′, many of the Xyrem subjects reported 0’s and 1’s. And after the study was discontinued they continued to have a long period of normalcy. One subject called just a month ago wanting to get back on Xyrem because she was just now experiencing return of her symptoms and the study she was in was done over 2-3 years ago. So I feel to continue forward with the first drug that offered a “cure” for FMS is criminal. It has been a huge disappointment and I hope we can do something about it.

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