![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by jrbecker on November 23, 2005, at 10:51:51
Xyrem(R) (Sodium Oxybate) Receives FDA Approval for the Treatment of Excessive Daytime Sleepiness in Patients With Narcolepsy
PR Newswire via NewsEdge Corporation :.
PALO ALTO , Calif., Nov. 22 /PRNewswire/ -- Jazz Pharmaceuticals announced today that Xyrem(R) (sodium oxybate) oral solution has been approved for marketing by the U.S. Food and Drug Administration (FDA) to treat excessive daytime sleepiness (EDS) in patients with narcolepsy.Xyrem was approved by the FDA in October 2002 as the first and only treatment for cataplexy in patients with narcolepsy. The expanded indication for use in treating excessive daytime sleepiness is "good news for narcolepsy patients," according to Richard Bogan, M.D., Assistant Clinical Professor, University of South Carolina School of Medicine. Bogan, who was an investigator in the clinical studies for Xyrem, said that "Xyrem has shown important clinical benefits in the treatment of EDS and cataplexy, the key symptoms of narcolepsy.".
The effectiveness of sodium oxybate for the treatment of narcolepsy symptoms was established in four multi-center, randomized, double-blind, placebo-controlled, studied over a period of time between 4 and 8 weeks. The studies examined three dosages of sodium oxybate (4.5g per night, 6g per night and 9g per night) taken in two equally divided doses (the first at bedtime and the second 2.5 to 4 hours later).
Two well-controlled clinical trials demonstrated that sodium oxybate at doses of 6g and 9g per night is effective at subjectively (as measured by the Epworth Sleepiness Scale) and objectively (as measured by the Maintenance of Wakefulness Test) improving excessive daytime sleepiness. The Epworth Sleepiness Scale evaluates the extent of sleepiness in everyday situations by asking patients a series of questions. The Maintenance of Wakefulness Test measures latency to sleep onset when patients are placed in a relaxed atmosphere and asked to remain awake without using extraordinary measures. In addition, two well-controlled clinical trials demonstrated that all dosages of sodium oxybate significantly reduced the frequency of cataplexy attacks. Furthermore, patients on the 6g or 9g per night doses saw significant improvements in quality of life -- with the majority of them rating much or very much improved on the Clinical Global Impression of Change (CGI-C) in Day and Nighttime Symptoms scale.
Xyrem was generally well tolerated and no treatment-related serious adverse events were reported. The most commonly reported adverse events (greater than or equal to 5%) in placebo controlled clinical trials associated with the use of sodium oxybate and occurring more frequently than seen in placebo-treated patients were: nausea (19%), dizziness (18%), headache (18%), vomiting (8%), somnolence (6%), urinary incontinence (6%), and nasopharyngitis (6%). These incidences are based on combined data from three well-controlled clinical trials and two smaller randomized, double-blind, placebo-controlled, cross-over trials (n=655).
"We are very pleased that the data from these studies show nightly Xyrem therapy reduces excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy," said Phil Perera, M.D., Chief Medical Officer of Jazz Pharmaceuticals.
About Narcolepsy.
Narcolepsy is a chronic, debilitating neurological disease, the primary symptoms of which are excessive daytime sleepiness, fragmented nighttime sleep, and cataplexy. The hallmark symptom of narcolepsy is excessive and overwhelming daytime sleepiness, even after nighttime sleep. EDS is present in 100% of narcolepsy patients and it causes people to become drowsy or fall asleep, often at inappropriate times and places. Cataplexy, the sudden loss of muscle tone, is the most predictive symptom of narcolepsy. Cataplexy can range from slight weakness or a drooping of the face to the complete loss of muscle tone and is triggered by strong emotional reactions such as laughter, anger or surprise.
More than 150,000 Americans are afflicted by narcolepsy, but fewer than 50,000 are diagnosed. Narcolepsy is as widespread as Parkinson's Disease or multiple sclerosis and more prevalent than cystic fibrosis, but it is less well known. Narcolepsy is often mistaken for depression, epilepsy, or the side effects of medications.
About Xyrem.
Xyrem is marketed by Jazz Pharmaceuticals through its wholly-owned subsidiary, Orphan Medical.
Sodium oxybate, the active ingredient in Xyrem, is a sodium salt of gamma- hydroxybutyrate (GHB). GHB is a substance with a history of abuse when acquired illicitly and used illegally. Abuse of illicit GHB has been associated with adverse CNS events including seizures, respiratory depression and profound decreases in level of consciousness, with instances of coma and death.
Xyrem is a Schedule III drug under the Controlled Substances Act and is only available through a restricted distribution system called the Xyrem Success Program(R). Please refer to the Xyrem package insert ( http://www.xyrem.com ) for full prescribing information.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is focused on helping patients by meeting unmet medical needs in neurology and psychiatry with important and innovative therapeutic products. Jazz Pharmaceuticals is aggressively building its product portfolio through a combination of commercialization and development activities. Based in Palo Alto , California, the company is committed to working closely with patients, patient advocacy groups and healthcare professionals. Jazz Pharmaceuticals acquired Orphan Medical in 2005. For further information, please visit http://www.JazzPharmaceuticals.com .
SOURCE Jazz Pharmaceuticals, Inc.
CONTACT: Mark Leonard, +1-847-267-9660, markdleonard@comcast.net , or Matthew Fust of Jazz Pharmaceuticals, Inc., +1-650-496-3777, mediainfo@jazzpharma.com.
<<PR Newswire -- 11/23/05>>.
Posted by lunesta on November 23, 2005, at 15:54:07
In reply to FDA gives nod to Xyrem for EDS in narcolepsy, posted by jrbecker on November 23, 2005, at 10:51:51
I was prescribed Xyrem for Fibromyalgia. It does indeed knock you out, but i hated the side effects, so i do not use it. The highest side effects 'group' is related to increased infections that concerns me. Its quite high for a drug like this, compared to some others.
Now I am shipped Xyrem monthly and flush it down the sink and black out my bottle with a market, as instructed. lol.
Anyone else benefit? The rebound dopamine causes intense anxiety, and I start getting constant respitory infections and night sweats.
Posted by zeugma on November 23, 2005, at 17:14:03
In reply to Re: FDA gives nod to Xyrem for EDS in narcolepsy, posted by lunesta on November 23, 2005, at 15:54:07
> I was prescribed Xyrem for Fibromyalgia. It does indeed knock you out, but i hated the side effects, so i do not use it. The highest side effects 'group' is related to increased infections that concerns me. Its quite high for a drug like this, compared to some others.
That is quite a concern of mine too.I manage the nonEDS narcoleptic symptoms with nortriptyline, and as long as I practice good sleep hygiene I don't have problems.
-z
>
> Now I am shipped Xyrem monthly and flush it down the sink and black out my bottle with a market, as instructed. lol.
>
> Anyone else benefit? The rebound dopamine causes intense anxiety, and I start getting constant respitory infections and night sweats.
Posted by Phillipa on November 23, 2005, at 20:33:54
In reply to Re: FDA gives nod to Xyrem for EDS in narcolepsy » lunesta, posted by zeugma on November 23, 2005, at 17:14:03
This is a med for sleep. Is this why GHB is called the date rape drug? Fondly, Phillipa
Posted by River1924 on November 24, 2005, at 0:19:14
In reply to Re: FDA gives nod to Xyrem for EDS in narcolepsy, posted by Phillipa on November 23, 2005, at 20:33:54
This is from the BBC (1999):
http://news.bbc.co.uk/1/hi/health/medical_notes/270247.stm
Rohypnol is a legitimate drug used in the short-term treatment of sleep disorders, but has been abused for more sinister purposes.It has been implicated in several date rape cases in the US, although there is no confirmed case of it being used in sexual assualt cases in the UK.
It is the brand name of flunitrazepam, and is a part of the Valium family. It is 10 times more potent.
The drug is not legally available in the US, but is in Europe and Mexico. In the UK it is only available on prescription, and it is illegal to possess it without one.
It rose to prominence as the date rape drug because it was colourless, odourless and tasteless - ideal for spiking drinks undetected - and causes sedation or euphoria in approximately 20 to 30 minutes....
Street names for Rohypnol include rophies, ropies, ruffies, roofies, roche, R-2, mexican valium, rib, and rope...
Users report mixing it with beer to enhance the feeling of drunkenness, and it has been reported to be used in combination with marijuana and cocaine, as well as heroin....
It is also used to ease the come down from a cocaine or crack binge, according to RaveSafe, a drugs information service.
When combined with alcohol, Rohypnol can make users shed their inhibitions. They can also suffer from loss of memory.
It has been labelled the date rapist's drug of choice....
"The predominant clinical manifestations are drowsiness, impaired motor skills, and anterograde amnesia."....
Are there other date rape drugs
Another drug, gamma-hydroxybutryate (GHB) is also reported to have been used to incapacitate victims in order to sexually abuse them.
The effects of GHB are similar to those of Rohypnol - dizziness, confusion and memory loss. It is colourless and odourless. It is most commonly found in liquid form.
However, a US study in 1997 showed that alcohol remains the substance most frequently associated with substance-assisted sexual assault.
Posted by lunesta on November 24, 2005, at 15:57:46
In reply to Re: FDA gives nod to Xyrem for EDS in narcolepsy, posted by Phillipa on November 23, 2005, at 20:33:54
hey Philpa babble mail me sometime if you want. I follow your posts and you and I may have similar problems. I have CFS/FM and the related pathogins and defiences the accompany them. I am being treated maybe we can help each other. Xyrem helps great for Fibromyalgia sleep and eventually pain, problem is if you have high anxiety the rebound (it only lasts like 3-4 hurs) then you wake up with anxiety if you have a disorder already. It is SO salty it can make you gag and vomit. But it is just publised check Xyrems website, that it is successful and they are now going to get it approved for Fibromyalgia next.
chronicfatigue@gmail.com is my email anyone can email me about CFS/FM/Lyme/MCS etc. I am a self acclaimed expert in those syndrome diseases and talk to many researchers etc, and also am a volunteer for the national CFIDS foundation and am part of the genetic study for CFS which i am so elated about since it free for me.
Posted by willyee on November 24, 2005, at 19:09:21
In reply to Re: Philpa regarding CFS /FM Lyme and Xyrem » Phillipa, posted by lunesta on November 24, 2005, at 15:57:46
Hey there,id like to mention something on xyrem real quickly.
First lol you have no idea how many people would kill to be able to get a legal means to this drug,lol theyu would have a heart attack if they knew it whas poured down the drain.
As far as the dopamine rebound,there is a good theory on this,its similiar to why alcholol also sometimes makes people have anxiety.
Hopefully this makes sense.......Ok gaba A recepors in the brain stimulate Glutamate,which is stimulative not INHIBITORY.More like a smart drug would be,for people with anxiety stimulated glutmate recptors can be a night mare.
GHB when taken in very small amounts actualy hits GABA A,these are doses of approx anywhere from 200 mg to 1 gram.Now its ur higher doses of 1-4 grams of GHB/XYREM that begin to greatly influenance gaba B recpetors,gaba B unlike gaba A is INHIBOTORY,relaxes you calms you,puts you to sleep.
Most peole need to take a fairly large dose of xyrem for this reason.ALCHOLOL in small amounts is said to do the same,small amounts of alclholol stimulate gaba A GLUTMATE and can worsen anxiety,where as larger amounts work on gaba B.Now as far as dopamine rebound,its believed the GHB rebound is not simply a release of dopamine but instead the ghb levels beginning to dwindle and drop as the drug exits,slowly the ghb levels make there way back to a gaba A amount thus creating that anxiety.
I think dopamine gets blamed way too often for things,dopamine actualy is BOTH stimulate and inhbitiory.Also if you research any ghb/xyrem user,and read about what they do to qwell "dopamine rebound" you will see almost all of them use some sort of benzo gaba med,if dopamine rebound was the cause then wouldent it make sense that a small dose of an antipsychotic which SURPRESSES dopamine instead be used?? This however is rare,in fact i never heard of one being used for rebound.
Now of course i dident come up with any of this,there is a good article that explained this in detail,i just dont have the time to search for it but can if anyone wants.But i do agree with it and dont believe its dopamine rebound,dopamine can be pleaseant,a ghb rebound is not,and it does feel more like a glutamte state.
As far as using xyrem therputicaly,if it were off labled id say 1.5 grams maybe 2 a day.Id also use a small portion of a benzo when i noticed rebound.Xyrem is non-toxic and leaves the body via h20,water.I think using a benzo for rebound rather than re-sing xyrem can keep people from devolping an addiction for it and running for it every time they feel a rebound.Instead they will stay stead fast in the dose amounts daily.
Now yess you would still use a benzo,but A you will use less benzo if u just used it alone so u can cut down,B also aside from using less benzo you are also taming your anxiety with s substance less likly to worsen depression in the process.
Xyrem/ghb is very unique,the doses introduced for sleep were shocking to the tons of people who use it daily for anxiety,most users doing so wouldent dream of going higher than a 2.5 dose.
Its a shame your only experieance with this valuable drug is in such a high dose range where its a whole different world.I have a lot of articles on it,feel free to email me at brklyn234@yahoo.com if u ever would like some,good luck
Posted by lunesta on November 24, 2005, at 20:17:54
In reply to Re: Philpa regarding CFS /FM Lyme and Xyrem, posted by willyee on November 24, 2005, at 19:09:21
Well I am nothin againt GHB, it just doesnt sit well with the increased infections. The whole rebond, whatever the glutamate/dopamine idea is porbably because i have underlying anxiety already and like u said i am prescribed um like 8ML twice a night lol.
Posted by zeugma on November 24, 2005, at 21:19:02
In reply to Re: Philpa regarding CFS /FM Lyme and Xyrem » willyee, posted by lunesta on November 24, 2005, at 20:17:54
> Well I am nothin againt GHB, it just doesnt sit well with the increased infections. The whole rebond, whatever the glutamate/dopamine idea is porbably because i have underlying anxiety already and like u said i am prescribed um like 8ML twice a night lol.>>
Provigil increases infection propensity too, and that's bad enough. No way am I making that more likely by adding Xyrem.
-z
Posted by utopizen on November 27, 2005, at 7:28:16
In reply to FDA gives nod to Xyrem for EDS in narcolepsy, posted by jrbecker on November 23, 2005, at 10:51:51
I tried Xyrem to combat my atypical depression (aka melancholia, featuring hypersomnolence, anhedonia, etc.)
Well I was an idiot.
Let me tell you, you can find a doctor to dx you and medicate you for anything if you go through enough and are smart enough and willing to take enough tests and have good health insurance.
That was sort of my problem. I was convinced I didn't have "depression" but simply a sleep disorder (I wasn't thinking rationally because of my depression).
It makes you so depressed the next day, I had extreme emotional lability-- I would cry at times if someone tried to approach me and say "What's up?"
Don't take it if you have a history of depression.
Also, do not take it unless you actually have exausted all other treatments. And keep in mind most of the time, you are not capable of understanding how big a role your mood plays in your vigilance.
Even if you have actual narcolepsy, I've never known anyone with it thrilled with life.
SSRIs can help, and certainly can't hurt.
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.