Sodium Oxybate for Fibromyalgia: Data are Promising
NEWSBRIEF: Jazz Pharmaceuticals says data from Phase III trials on JZP-6 (sodium oxybate) show the drug can ease pain, fatigue and sleep disturbance in people with fibromyalgia.
Sodium oxybate is the active ingredient in the narcolepsy drug Xyrem. It's already widely used, off label, as a fibromyalgia treatment. It's a controlled substance, however, and requires close monitoring by your doctor.
Jazz says side effects were mild to moderate and included headache, nausea, dizziness, vomiting, diarrhea, anxiety and sinusitis.
The company has completed a second Phase III trial and expects to announce results within the next few months. If results continue to be positive, Jazz expects to file a New Drug Application with the FDA by the end of 2009. If approved, the drug could conceivably come on the market sometime in 2010 or 2011.
- Learn More About JZP-6 Sodium Oxybate
Comments
I took Xyrem for Fibro for a little over two years, and only stopped after my new insurance carrier stopped covering it about a year ago. My out of pocket cost would have been over $650 per month to continue the therapy.
I must say that I have fantasized about all different ways to be able to access a supply of this drug again.
When I started taking it in early 2005, it was almost a “Lazarus get up and walk, you are healed” experience for me. I felt better immediately, and within a few weeks I noticed that I was steadily losing weight–nearly 40 pounds. I know that this is an unusual side effect, but not unheard of.
In early 2006, I took a bad fall and had to have surgery to fuse my C4-5 (neck) vertabrae. It seemed as if after that incident I got less benefit from the Xyrem, and more side effects. The side effects I experienced were mostly an increase in cramping at bedtime, a much more frequent inability to fall asleep–and when I did have trouble getting to sleep I would be ravenously hungry. My husband said I would often wake him doing the exercises I do to relieve my pain–except that I would be in bed with him, asleep.
I know this is an “orphan drug” that involves costly trials, but I also know that this is a product that was widely available in health food stores until the late 80s.
I wonder if the company that makes Xyrem would be willing to provide it at much lower cost to those of us uninsured.
I almost immediately felt the impact of getting a good night’s sleep. The support system is great. They are always available should you have a question or a problem. If you change any other medications you are on, you need to tell them in case it interacts with the Xyrem. I can’t wait until they get the 4 hour life extended. I would love to be able to sleep for 8 hours straight. I still will wake up when a storm front comes through. I occasionally have a night where it is as if I haven’t taken any meds at all. Nights like that are now, Thank Heavens, few and far between. I agree about the expense. I have insurance and I still can barely afford it. It’s worth it to get the sleep that I do!
I’ve been using Xyrem for a while now. It’s wonderful. Taste nasty but it works.
I take a dose, set my alarm for 2.5 hrs later, take another dose. If I do this, I get at least 6 hours of sleep. But this sleep is good, restorative sleep.
My doctor is a huge fan of Xyrem and is disappointed that more doctors won’t use it.
I use 9grams a night which cost 1100$/month