There's another way of looking at this. The FDA is going to trash any drug
that doesn't have a company (and consequently politicians) behind it. They
explicitly said that one reason they took trytophan off of the market was
because it was eating into the sales of pharmaceutical companies'
anti-depressants, and that this wasn't good for psychiatry because
pharmaceutical companies fund most psychiatric research. If you don't
believe this check out Shulgin's two books.
The glass might also be half*full. Now that someone is willing to shell the
$300 million out that it costs to get a drug approved here in the US, Gamma OH
will have an advocate, and hence be sold.
As you might appreciate on my posts about morphine being helpful in cases of
OCD when even hacking 4 parts of the brain didn't help, it's too bad morphine
and the other opiates are no longer under patent.
In article <36d3569c.8475393 at news.twics.com>,
patanie at pasdepubyahoo.com (Claude de Contrecoeur) wrote:
> Look at the duplicity of the american FDA. They have labelled Gamma-OH
> a "dangerous" drug and,now,look what they do...
> This is typical of US commercial maneuvers to attack foreign
> products:demonisation,until they can catch up.
>> Source: Press Release from Orphan Medical, Inc.
>> PR Contact: John Howell Bullion, Orphan Medical, Inc. , (612) 513-6900
>> Orphan Medical Announces FDA Approval to Initiate
> A Treatment IND Program
> for Xyrem (Sodium Oxybate) Oral Solution
>> MINNEAPOLIS, Minnesota December 17, 1998 Orphan Medical, Inc.
> ORPH) announced today the approval by the Food and Drug Administration
> (FDA) of a Treatment IND (Investigational New Drug) for Xyrem (sodium
> oxybate.Gamma-OH,in French) oral solution. Xyrem is intended to treat
> narcolepsy, including
> the reduction of cataplexy. Narcolepsy is a chronic neurologic
> characterized primarily by unavoidable daytime sleep episodes and
> cataplexy. Cataplexy, a sudden and often total loss of muscle control,
> affects the majority of narcolepsy patients. Narcolepsy is estimated
> affect at least 125,000 patients in the United States.
>> During the Treatment IND, expected to begin in the first quarter of
> the Company will collect additional clinical data necessary for the
> submission of a new drug application (NDA) to the FDA. The FDA permits
> investigational drug to be used under a Treatment IND ---->if there is
> sufficient evidence of safety and effectiveness and the drug is
> intended to
> treat a serious disease.<---- no comment.
>> ``This is a very important milestone for Orphan Medical,'' said John
> Bullion, CEO of Orphan Medical. ``The initiation of a Treatment IND
> enable the company to seek reimbursement for certain development costs
> while we gather additional clinical data.''
>> Orphan Medical, Inc. is dedicated to patients with inadequately
> treated or
> uncommon diseases. To this end, the Company acquires, develops, and
> products of high medical value that address these diseases within
> strategic therapeutic market segments.
>> Orphan Medical's Internet Web Site address is http://www.orphan.com>
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