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New Drug Application for sodium oxybate as fibromyalgia treatment accepted by FDA

  [ 50 votes ]   [ 12 Comments ] • February 21, 2010

Jazz Pharmaceuticals, Inc. announced Feb 19 that the U.S. Food and Drug Administration (FDA) had accepted for filing the New Drug Application for the prescription drug JZP-6 (sodium oxybate, brand name Xyrem®) for the treatment of fibromyalgia symptoms. Xyrem is a central nervous system depressant. It is now FDA approved and available only under a special program for patients with narcolepsy - to support night time drowsiness and thus reduce excessive daytime sleepiness and sudden loss of muscle strength. (It is also a street drug of abuse – known as “GHB.”)

Fibromyalgia studies have focused on the drug's ability to improve sleep quality, fatigue, and pain.

According to the company's press release:

“Based on a standard 10-month review, the target date for the FDA to complete its review of the New Drug Application under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.

“The submission is based on a comprehensive clinical development program including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality. Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature and similar to those seen in previous trials with narcolepsy. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.”
Note: For background, see for example the full text article “Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: A randomized, double-blind, placebo-controlled, multicenter clinical trial,”  Arthritis & Rheumatism, Jan 2009, by Russel J, Perkins AT, Michalet, JE.

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Article Comments Post a Comment

Posted by: Juloo
Feb 22, 2010
Yay! Yay! Yay! Aetna -- I'll be coming for you!
Reply Reply

Great news
Posted by: DiamonDie
Feb 22, 2010
I've been waiting for this for quite a while. Hope the NDA will go through - Xyrem is a much better treatment for fibromyalgia than any of the three that are currently FDA approved for the purpose (of course there are hundreds of other medications that can be used to treat fibromyalgia, but the FDA approval carries a lot of weight).
Reply Reply

Are You Kidding ????
Posted by: Earth
Feb 24, 2010
GHB, also known as "the Date Rape Drug," has a negatively impressive reputation for possible abuse. I hate to consider if this formula is approved for the tens of millions fibro sufferers via simple prescription, making a pharmaceutical quality of this available to tweakers & abusers of all ages.
Reply Reply

very small amounts and is highly regulated
Posted by: lovecaz3
Feb 24, 2010
This medicine is highly regulated and is only sold in one pharmacy in the country.

The amount that is prescribed is very small and does not compared to what was taken on the street.

It produces a natural hormone that your body produces.Unlike all the pain meds etc I was on before which have more potential for abuse It has been life changing for me.


I have been on Xyrem for a year now and I am Fibro Free!
Posted by: lovecaz3
Feb 24, 2010
I suffered for over 7 years with chronic fatigue and fibromyalgia. I went to every type of specialist you could think of and tried almost every treatment and medicine the doctors would prescribe in my mid 30's I was on a hand full of meds. From prednisone, muscle relaxers, cymbalta and heavy duty pain meds. None of which would really help me but it would take the edge off some of the symptoms.I think out of all of them the lyrica gave me the most improvement but still was suffering. I noticed the colder weather did exacerbate my symptoms and living in central NY it is cold most of the year. So I relocated to FL. The weather helped some but still was suffering and on many meds. Than I went to a Doctor a sleep specialist(one test I have not taken sleep study!)in the Tampa area who has done special clinical studies on Xyrem. He sent me for my sleep study and found I had narcolepsy!My brain does not produce the hormone hypocretin which helps put you into a deep restorative sleep. In this phase of sleep you body repairs and restores it also rids you body of toxins.So I have literally not slept for seven years even though I thought I was sleeping all the time. I was only able to go into a light phase of sleep. He informed me he has found a connection with a majority of his fibromyalgia/ chronic fatigue patients with some form of a sleep disorder. I am now pain and fatigue free!I do not take handfuls of medicine anymore. I only need the xyrem.I have my life back!!!! It did take time to learn and adjust how to take this medicine with close guidance of my Doctor I would say with in two months I was totally free of Fibromyalgia and fatigue and was able to stop all other meds I was on. My only concern is that not all Doctors have the experience and knowledge on how to administer this medicine and it is not always tolerated well and may discourage patients who are not guided correctly and they may stop before they get the full effects.I strongly suggest a sleep specialist who is experienced with the drug and not a rheumatologist.
Reply Reply

Posted by: sh2o
Feb 28, 2010
Can you name your doctor? I live in Winter Haven, FL and would like to do a sleep study also. Thanks!


Xyrem vs Lyrica ?
Posted by: lucysun
Jul 21, 2010
lovcaz3 said "None of which would really help me but it would take the edge off some of the symptoms. I think out of all of them the lyrica gave me the most improvement but still was suffering."

I would be curious to know how your experience with lyrica compared with Xyrem? How were you still "suffering" on the lyrica, and what was different/better about the Xyrem results?

I am currently debating which one to try for my fibromyalgia.


Dr Perrino
Posted by: lovecaz3
Mar 1, 2010
The Doctor is Dr. Perrino


Not so simple
Posted by: Juloo
Feb 24, 2010
Xyrem is already available by prescription for narcolepsy with cataplexy. The potential of having fibro added to treatments will hopefully allow patients to have insurance help pay. A month's supply costs over $600 (more like $1,000 depending on dosage, which is very individual). This is not a 'simple' prescription to get. As it is an orphan drug, only one pharmacy sells it. Doctors must be registered with them to prescribe it, and patients must complete a short education course to be eligible for a prescription. As for the good side, having a 'normal' day, not feeling like I'm walking through life half-asleep and in pain, well, that's what makes this news very welcome.
Reply Reply

Look What I Found
Posted by: Earth
Feb 24, 2010
About Xyrem:

Indictment of Doctor Tests Drug Marketing Rules

By ALEX BERENSON Published: July 22, 2006/New York Times

This adds another interesting slant on Jazz Pharmaceuticals and its history in bringing GHB to the market.


Posted by: sh2o
Mar 1, 2010
I found Dr. Perrino - thanks very much. I am curious how they test for hypocretin levels. I have read that spinal fluid must be drawn and tested. Is that what you did? I'm not sure that have the stomach for that.
Reply Reply

Re: Are you kidding?
Posted by: seasam
Mar 16, 2010
I think "Earth"s comment reflects very clearly the hysteria surrounding drugs in this country. CFS/fibro sufferers have too few options as it is. ANY drug that works and is well tolerated is a blessing. The demonization that this drug in particular has been subject to serves no one but over-zelous law enforcement and the drug companies. Sodium oxybate has been shown to be very well tolorated, safe and possibly even rejuvanative. Keeping it from treating anyone suffering from CFS/Fibro because a small irresposible segment of the popoulation produced it themselves and abused it is just unfair. "Tweakers" will simply find a new drug to abuse, as they always do, and meantime it's formula get's passed (with exclusivity enforced by the DEA at enormous tax-payer expense) to a drug company that charges $600. a month to some poor person for whom nothing else works and who's illness probably prevents him from working as much as a healthy person. Sodioum oxybate became ubiquitous in the drug scene because is was easily and EXTREMELY inexpensively produced in huge quantity at home. How could it possibly cost so much to supply in small quantity to someone with a legitmate need? I believe sodium oxybate will continue to prove itself useful in medicine, and we should ask ourselves why we allow our government and indusrtry to conspire to keep it from us, except at a huge ransom. Drug abuse in the community at large is a seperate issue.
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