BREAKING NEWS: The U.S. FDA has rejected the proposed fibromyalgia drug sodium oxybate, saying it needs the manufacturer, Jazz Pharmaceuticals, to provide several things before the medication could be approved.
In the FDA's response letter to Jazz, the agency said it needs:
- Better patient population data from trials,
- Safety data,
- And a proposed Risk Evaluation and Mitigation Strategy (to show how it plans to keep the drug out of the wrong hands.)
Jazz released a statement saying the company plans to meet with the FDA to clarify the response letter before it evaluates the next steps for this drug.
The rejection shouldn't come as a shock to anyone -- back in August, an FDA advisory panel recommended against approval by a vote of 20 to 2. The FDA can go against this recommendation (as it did with Lyrica), but it rarely does. The panel's biggest concern was public safety, because sodium oxybate is chemically related GHB, the "date rape" drug.
Sodium oxybate is currently on the market as the narcolepsy drug Xyrem. To get Xyrem approved, Jazz had to put extremely stringent control measures in place. Even then, it was classified as an "orphan drug," meaning that it has a very limited usage. However, the fibromyalgia market is enormous when compared to the tiny narcolepsy market, so it's understandable that the FDA would be concerned about making a potentially dangerous drug more widely available.
This rejection isn't a flat out "no," but more of a "not right now." If Jazz can get the requested information to the FDA, it's possible that it would be approved. However, it could take years to compile those data and go through the approval process once again.
If it is approved, sodium oxybate may still be out of reach for many because:
- It's addictive,
- The safety screening and monitoring will exclude some people and be unattractive to others,
- It's an expensive drug -- to the tune of a couple thousand dollars a month.
Do you think we'll ever see this drug approved for fibromyalgia? Have you taken it, or have you tried to get it and been denied? Leave your comments below!
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I was diagnosed with narcolepsy in late 2007, and have been taking Xyrem since the first of the year 2008. I also have been diagnosed with chronic fatigue syndrome, fibromyalgia, and rheumatoid arthritis.
On nights when I don’t take the medication (both before I started it and nights when I feel nauseated), I have a combination of insomnia and pain and keeps me up for most of the night. When and if I actually do sleep, I will almost always feel like I’m in a fog for most of the next day and my pain levels will be higher than when I take it.
In my case, my body skips the phase of sleep where it “self-repairs”, and Xyrem forces my sleep to follow the normal pattern. When I take it, I sleep soundly most nights (unless there are other factors), and only my alarm to take the 2nd dose (4 hours from the first dose) or a full bladder (it moves through your system very quickly) will wake me up. In the morning, I feel generally refreshed – which was an almost foreign experience initially. It can take a little while to “wake up” – you are advised to wait 6 hours from the 2nd dose before driving – but a full bladder, again, encourages you to not stay in bed all morning.
When I wasn’t having flares and complications from other problems, it helped me function much better. When I have other problems, it helps to lessen them, but isn’t a cure-all.
As I have written before, I’ve been on xyrem for over 4 years now, two doses a night. I don’t need an alarm to wake me up for the second dose, when Xyrem wears off, I’m awake and take my second dose.
Before xyrem I was bedridden. For years I had no quality of life. I lived, breathed, ate, that’s about it. oh, and saw my drs. Now for the last four years I’m able to drive again, study at a community college, take feldenkrais, pilates, and aerobic classes, see movies, shop, visit children, have an almost full life. I still need to rest more in the afternoons than other women of my age, I think. (I’m 70 now).
We need Xyrem to be cheaper and more available to other people with fibromyalgia. It’s the only drug that has helped me to recover and I swear by it. Too many people are suffering right now from lack of restorative sleep. This problem does have a solution and Jazz, found it.
I was given Xyrem by a “rogue” pain mgmnt specialist (rheumatologist), who has since had his license to dispense pain meds revoked. It was a revelation to me! For the 1st time in my life, I awoke in the morning refreshed, alert, with my pain levels greatly diminished, and feeling better than I had in many years. I, too do not get the “repair sleep cycle”, not even with normal sleep meds such as Ambien or Sonata. Yes, Xyrem has great risks, as do a lot of things you have to take related to your “medical diploma” illnesses, as a friend calls CFS, Fibro, Osteo/Rheum and all the other stuff we deal with. But if done properly, with supervision and care, it can be truly life-changing.
I hope they allow the newer drugs and in fact I am going to ask my physician about Xyrem. I was diagnosed 7 years ago with FM and any of the physicians I have seen are scared to prescribe too much of anything for fear of addiction. I take Tramadol and Klonopin and neither do very much for the pain. I can’t lose weight because of pain issues and exercise. I am tired of being in pain and the physicians thinking I am going to become an addict. I guess I should try to become addicted to the pain that comes with FM. I can’t sleep good. I take lots of good supplements. Still the pain is always there.
Yes this drug is expensive, but with insurance my payment is not several thousand a month, but only 55/month. This is my miracle drug. I have stopped taking strong pain meds on a regular basis, I have cut my total pills from about 16 per day to 8/day. My sever pain is no longer every hour of every day but maybe several times a week. I have been on this Program for almost a year.
I waited for months to be accepted into the Xyrem Success Program. It has changed my life and allowed me to work and function at a somewhat normal level. Before beginning the program I spent days without restfull sleep due to the intense pain. I lived in a fog which threatened my career. My family and my doctor wanted me to go on disability. Since beginning the program I sleep peacefully. I wake up rested and am able to fuction (get dressed and get my children off to school). I no longer live in a constant fog. I am able to work and live a productive life.
I have narcolepsy, chronic fatigue, and fibormyalgia. I have been taking xyrem for many years and definitely discovered an immediate improvement of my fibro pain.
I have severe FMS, TMJ, CFS, endometriosis, Trigeminal Nerve pain, RLS, and I have had insomnia since was a child. I had to take everything from Benedryl, Doxepin, Xanax, Soma, Darvocet — just to *hopefully* fall asleep. Sometimes I’d be awake for 2-3 days straight, unable to drive b/c i was so sleepy. My sleep was fitful, non restorative, and I’d awaken every 1-2 hours to pee, or to move b/c I was in pain. I’d feel worse in the morning than when I went to bed. I have been disabled for over half my life; 4.5 years ago I started Xyrem. For the first time, i *slept*! Unlike other meds, I tolerate it well, and I started actually being able to build some muscle tone (I had sever muscle weakness before). MY EDS subisded, and I was able to get off a lot of the meds I have been on for years.
Now Medicare Part D disqualifies me from the SDS Success Program, and I a FRANTIC! I was doing well on the Xyrem, but two years ago I had internal injuries which wrecked my digestion. I can’t eat raw foods, spices, gluten, meat, etc.I am very weak, and the ONLY respite from pain I;ve received is that Zyrem allows me to sleep. when I have run out, I can’t sleep and my pain is so excruciatingly, that I can’t stand it (I know you all have been there, that is why we joined this support group, right?). Suffice it to say, I am desperate. Does anyone know of a viable, safe Xyrem substitute? None of the other sleep meds work for me; I can’t afford my dosage (over $3,000.00 per month). I can’t imagine going back to the misery that was my life before Xyrem. I am unable to fly to get it in England or Germany (I have a valid prescription) due to an inner ear problem that is serious. I am open to any non toxic ideas, please email me. Thanks!