New fibromyalgia drug JZP-6 (Sodium Oxybate) from Jazz Pharmaceuticals On Its Way
Photo by ppdigitalMove over Cymbalta, Lyrica and Savella
A new fibro drug may be on its way. The FDA has just accepted the filing by Jazz Pharmaceuticals, Inc. for a new drug application called JZP-6 (Sodium Oxybate) for the treatment of fibromyalgia (FMS). The expected date for its release is this October 2010.
If released, this will be the fourth FDA-approved fibromyalgia medication. What sets this drug apart from the three other fibro meds? A new ingredient: Sodium Oxybate.
In two Phase III clinical trials, the Sodium Oxybate treatment "significantly decreased pain and fatigue, as well as improved daily function, patient global impression of change, and sleep quality."
The Sodium Oxybate ingredient has not been evaluated by the FDA for treating fibro. However, it has already been approved for treating narcolepsy and is currently marketed by Jazz Pharmaceuticals as Xyrem (Sodium Oxybate).
JZP-6 Sodium Oxybate Will Take Over 15% of the Fibro Drug Market
"Although factors such as safety, abuse potential and risk of illicit use will ultimately constrain its overall market potential, sodium oxybate's expected premium price will translate into robust sales, we expect sodium oxybate will be prescribed primarily by specialists to patients with the most severe fibromyalgia who are unresponsive to or cannot tolerate other medications."
Drug Downsides
By examining Xyrem (Sodium Oxybate), which is made up of Sodium Oxybate like JZP-6, we can get an idea of some of the potential downsides that the anaylst mentions:
- Xyrem comes with serious warnings. Side effects for Xyrem are severe with the worse being respiratory depression, coma and death. Xyrem's warning box is extensive.
- Risk for drug abuse and addiction as a recreational party drug is high. Xyrem contains Gamma-hydroxybutyric acid or GHB, a commonly abused street drug.
- Inconvenient to take. One dose of Xyrem is taken at bedtime and the second dose requires waking up 2-1/2 to 4 hours later.
Is JZP-6 Right for You?
Hopefully, the clinical trials will give a clear indication of whom should take JZP-6 and what the side effects are so fibro patients can make an informed decision about whether the benefits outweigh the risks.
Apparently, some people with fibro may already take Xyrem off label. Personally, I tried each FDA-approved fibromyalgia drug - Cymbalta, Lyrica, and Savella - as they came to the market in hopes that one would provide real pain relief.
I am currently taking Savella, and have had the best results out of the three with the most tolerable side effects. It has reduced my overall body pain but has not had any effect on my fatigue, sleep disorder and myofasical pain centers in my neck, shoulder and back.
Because I have a severe fibro case and since JZP-6 Sodium Oxybate is said to be effective in all three major fibro problem areas (pain, fatigue, sleep), I would seriously consider trying this new fibro drug if my doctors recommended it.
Cause for Celebration?
Do those of us living in the Fibro World have reason to rejoice that even a potentially lethal drug like Sodium Oxybate is available for fibromyalgia treatment? Ironically, yes.
It is an indication that research and money is being directed towards finding treatments and drugs to help fibromyalgia and chronic pain sufferers. Perhaps it is only a matter of time before something that is both safe and effective hits the market.
Would you be willing to try JZP-6 Sodium Oxybate?
Dot
This article was featured in Grand Rounds
Don't miss MD Whistleblower's very lively edition of Grand Rounds this week. Not only do we get a great collection of medical posts, we're also treated to a terrific tour of the digestive system!
Dot gives a preview of a new medicine that is under FDA review for fibromyalgia. Blog posts that discuss a single medicine can be hypnotic, but Dot has made her post lively and personal. It’s well done and worth the read.
Also, check out Selena's post about what other's are saying about the med Xyrem at Oh My Aches and Pains!
Dot on February 19, 2010 5 Comments Share Email | in Blog Carnival, Grand Rounds, Health and Medical News, JZP-6 Xyrem, Medication 
Reader Comments (5)
I have fibromyalgia. I am sensitive to meds. I don't think the risks of this med are worth it for me--I read it is a paralytic and you can be paralysed for 4 hours after taking it. No thanks.
Kathy - I can definitely appreciate your concern. The side effects are indeed alarming and for that reason, I think doctors are required to be extra vigilant with Xyrem. I've also noticed that most people in the Fibro World are very sensitive to medications. I know I am, just like you. My doctors always start me on the very smallest dose possible with every med. Has this been your experience too? Thanks for your comment - here's hoping that we both find the perfect medication regime! Or better yet, no meds at all.
Great site. A lot of useful information here. I�m sending it to some friends!
The concerns listed are overblown. If you will take some time to research gamma-Hydroxybutyric acid, you will find that it has been around for a long time and was used extensively in europe starting in the 1960's. It was sold over the counter here in the US in health food stores for many years, first as a sleep and and secondly athletes used it because of some evidence that GHB can increase growth hormone production. It was only made illegal after some people enjoyed the effects of taking it and staying awake. Of course while it was over the counter you could buy it very inexpensively. Now it's going to be prescription only and tightly monitored, so very expensive. From the research it appears very difficult to take a fatal dose of GHB. However, it will put you in a very deep sleep that is hard to be roused from (thus the coma description). Most if not all deaths related to GHB show that it was taken with other drugs, particularly alcohol.
Physical Therapist- Thanks for sharing Fibro World with your friends. I can't think of a greater compliment!
Kyle- Thank you for sharing your knowledge about Gamma-Hydroxybutyric acid (GHB). It is unfortunate that GHB has been misused as a recreational drug. It makes it much more difficult for those who may really medically benefit from GHB-containing product Xyrem to obtain it. On top of this, most people in the Fibro World who may benefit require multiple and often expensive medications to contend with their many symptoms and chronic pain.