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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 7 of 7. This is the beginning of the thread.
Posted by spike4848 on January 20, 2002, at 20:47:31
Hey Guys,
Why is adrafinil not availible in the U.S.? Has any company made plans to submit it the FDA for approval? Are there any safety concerns?
Sorry if this has already been discussed in prior posts.
Spike
Posted by IsoM on January 20, 2002, at 22:16:01
In reply to Why no Olmifon/Adrafinil in US?, posted by spike4848 on January 20, 2002, at 20:47:31
Spike, Olmifon (adrafinil) is made by Lafon Laboratories in France. They probably have a patent on it still. The pharmaceutical company is a relatively small French family-owned company without the money & backing to push for an American patent.
Lafon has been acquired in Dec 2001, (supposed to be partnership-style) by Cephalon, a large American-based international company that specialises in neurologic & cancer drugs. Perhaps they'll have an interest in marketing adrafinil in North America, or (& my pessimism is showing) will downplay adrafinil & push the more pricey modafinil (Provigil) which both Cephalon & Lafon markets now.
Seeing that I've finally found what works so well for me, I fully expect it to become unavailable in a matter of time.
> Hey Guys (AND DON'T FORGET, GIRLS!!!),
>
> Why is adrafinil not availible in the U.S.? Has any company made plans to submit it the FDA for approval? Are there any safety concerns?
>
> Sorry if this has already been discussed in prior posts.
>
> Spike
Posted by spike4848 on January 20, 2002, at 23:06:58
In reply to Re: Why no Olmifon/Adrafinil in US? » spike4848, posted by IsoM on January 20, 2002, at 22:16:01
> Seeing that I've finally found what works so well for me, I fully expect it to become unavailable in a matter of time.
LOL .... I will get out my 8th grade chemistry set and help you make some IsoM!
> > Hey Guys (AND DON'T FORGET, GIRLS!!!),
Sorry ... hows "Hey Everyperson, Hey everyindividual, Hey You" ....Spike
Posted by IsoM on January 20, 2002, at 23:33:24
In reply to Re: Why no Olmifon/Adrafinil in US?, posted by spike4848 on January 20, 2002, at 23:06:58
> > Seeing that I've finally found what works so well for me, I fully expect it to become unavailable in a matter of time.
>
> LOL .... I will get out my 8th grade chemistry set and help you make some IsoM!Heck, my college level chem texts don't even help!!! ;)
**********************
> > > Hey Guys (AND DON'T FORGET, GIRLS!!!),
>
> Sorry ... hows "Hey Everyperson, Hey everyindividual, Hey You" ....When someone forgets my name, I just to tell to use ""what's-her-face". I answer to it.
Posted by Rick on January 21, 2002, at 4:53:58
In reply to Re: Why no Olmifon/Adrafinil in US? » spike4848, posted by IsoM on January 20, 2002, at 22:16:01
> Perhaps they'll have an interest in marketing adrafinil in North America, or (& my pessimism is showing) will downplay adrafinil & push the more pricey modafinil (Provigil) which both Cephalon & Lafon markets now.
Seeing that I've finally found what works so well for me, I fully expect it to become unavailable in a matter of time.
> Given how lucrative the antidepressant market is (and adrafinil has an antidepressant indication in France, while modafinil doesn't), I would expect Cephalon to at least look into the possibility of marketing adrafinil here -- especially since it doesn't cause sexual dysfunction like the SSRI's.
BUT, in addition to the formidable "works-for-IsoM" hurdle, I see two more things adraf may have going against it:
-- I believe it's marketed in France mainly as an energizing AD for the elderly, which sounds pretty limiting, and
-- The need for liver-function tests. The FDA and the public are especially sensitized to this right now with the liver-failure problems that have hit some high profile drugs recently (especially Rezulin and Baycol, and to a lesser extent Serzone). The ambulance-chasers are having a field day.
Rick
Posted by Rick on January 21, 2002, at 5:12:57
In reply to Re: Why no Olmifon/Adrafinil in US?, posted by Rick on January 21, 2002, at 4:53:58
Posted by spike4848 on January 21, 2002, at 10:17:01
In reply to Misplaced Carat above- Reply starts with Given How (nm), posted by Rick on January 21, 2002, at 5:12:57
This is the end of the thread.
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