GHB approved by FDA

[harddtime]

here's another article from the orphan website, i hate this scheduling bullshit


ORPHAN MEDICAL ANNOUNCES FDA APPROVAL OF XYREM®
July 17, 2002.

MINNEAPOLIS – July 17, 2002– Orphan Medical, Inc. (Nasdaq: ORPH) announced today that the U.S. Food and Drug Administration (FDA) has approved Xyrem® (sodium oxybate) oral solution to treat cataplexy, a sudden loss of muscle tone associated with narcolepsy. Xyrem is the first approved medication indicated for the treatment of cataplexy.
Narcolepsy is a chronic neurological disorder affecting approximately 140,000 Americans. An estimated 60-90 percent of narcolepsy patients experience cataplexy. Cataplexy is a debilitating symptom of narcolepsy usually triggered by strong emotions such as laughter, anger, or surprise. In its most severe form, cataplexy can cause a person to collapse during waking hours.

Xyrem (sodium oxybate) is a central nervous system (CNS) depressant and should not be used in conjunction with alcohol or other CNS depressants. Sodium oxybate is *** (gamma hydroxybutyrate), a known drug of abuse. The abuse of *** has been associated with a number of important CNS adverse clinical events, including seizure, respiratory depression, and profound decreases in level of consciousness, with instances of coma and death. Even at recommended doses, use has been associated with confusion and other neuropsychiatric events. Reports of respiratory difficulties occurred in clinical trials.

Xyrem is a Schedule III controlled substance. In addition, its distribution is governed by the FDA’s Subpart H regulations. To comply with these regulations, the Company has developed a rigorous system that makes Xyrem available to patients from a single, specialty pharmacy. Both physicians and patients must receive an education program from the Company before obtaining Xyrem. Orphan Medical has worked closely with the FDA, DEA and law enforcement agencies to develop strict distribution and risk-management controls designed to restrict access to Xyrem to the intended patient population. The Company has begun the hiring and training of approximately 35 additional sales employees who will call on accredited sleep centers, and other physician specialists treating those with cataplexy. The Company plans to launch Xyrem at the beginning of the fourth quarter.

“We have worked with physicians, patients, and FDA for nearly eight years to bring Xyrem to patients with cataplexy,” said John H. Bullion, Orphan Medical Chairman and Chief Executive Officer. “We commend the FDA’s action that recognizes the therapeutic value of this important product. We are very pleased with this long-sought approval, and we are continuing work to understand fully Xyrem’s mechanism of action. We also expect to complete by the end of 2002 the clinical portion of the Phase III(b) trial designed to assess the efficacy of Xyrem in incrementally reducing excessive daytime sleepiness as a supplement to stimulant therapy.”

Please join the management of Orphan Medical at 9 am Eastern time for a conference call to discuss today’s news announcement regarding Xyrem. The dial in numbers are 877-626-0595 (Domestic) and 706-634-1208 (International). The pass code to enter the call is 4839700. This call is also available on the Internet at: http://www.firstcallevents.com/service/ajwz362841482gf12.html

On July 23, 2002, Orphan Medical will hold a conference call to discuss its second quarter results and provide guidance for upcoming quarters.

Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon diseases treated by specialist physicians. Orphan Medical's Internet Web site address is www.orphan.com

 

[3Vandoo]

 

[therookie]

when will it be at local pharmacies? or available for prescription?

It is being produced, given and sold at such a tight watch dont plan on getting your hands on any....

And the amount they are talking about for treatment isnt enough to get hight,let alone its going to be extremely expensive for those who are candidates to use it.

 

[JESA1]

That sounds like great news to me Genarr3, I dont think its going to be like Oxycontin. Oxycontin are addicting and you get withdrawals. Remember whats the pharmaceuticals reason for putting it on the market. We all know its not to HELP anyone. Its for that good old american $$$$ dinero. As long as theres people to buy it there be people to sell it.

Come on now even the FDA has got to know it shouldnt be schedule one and thats what its doing. Schedule III just like valiums and xanax. And Oxycontins are schedule II for cancer only. Adderals and Ritalin I believe are schedule II. The FDA just wants a little $$ out of something that doesnt have a fuckin patent. No patent or old patent means less $$ and priority for The FDA. ALSO i dont care what anyone else says you all should agree with me GHB is defintly safer over longterm than Ambiems or any of the other benzos.

All that date rape shit is just scare tactics that have always been used.

It reminds me of those movies back in the 30's like reefer madness that says that if you smoke weed once. youll immediatly start jacking off uncontrollably and look for the first victim to stab for your next high. And if you cant find anyone to stab youll pimp your own mother. Its bullshit.

Well before I rant on about politics lets give it up for the greedy little drug companies who realized that there is a market for this shit. US and if they market it like Paxil and Prozac and Zoloft, everyone will be on it pretty soon.

At least we made some ground in this war against ignorance that politicians start by scaring the baah baah sheeplike public into believing.


P.S. I wonder how the orphan stock is gonna do? It could be the next trend in dealing with sleep disorders.

 

[proud13]

Very true Jesa1,
The whole date rape thing came about once a few people were killed or raped and the mommies and daddies got powerful lobbying groups together and forced their senators to make it a scheduled drug. Alcohol is far more dangerous and just look at all the DUI's, deaths, liver problems, etc associated with that.