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Just over a year ago Dr Marty Sawaya announced some shocking
news on the Bald Truth
Show. Dr Sawaya had been testing a new hair loss drug
code-named GI198745 or otherwise known as Dutasteride. She
said the results were so dramatic that researchers could easily
see which person was getting the placebo and which person
was getting the active ingredient. In fact the results were
so impressive they were better than she had seen with any
other drug she had ever tested.
What shocked Dr Sawaya
was the decision by Glaxo Welcome, the company who owned the
drug, to suddenly pull the plug on the Phase 3 trials. They
did so without warning and in spite of the excellent results
that were being seen. According to Dr Sawaya, she received
a letter from Glaxo stating the Phase 3 trials were on hold
and they requested that all equipment be sent back to Glaxo.
This sudden cancellation of the drug's trial has led to a
lot of speculation as to why Glaxo pulled the plug. It has
been theorized that Glaxo felt that because of Propecia's
lackluster sales, Dutasteride would not be a moneymaker for
them. Another possible reason floated is that Glaxo had been
involved in a merger with SmithKline Beecham that was recently
finalized on Dec 27, 2000. It is possible that Smith Kline
did not want to enter into the hair loss market or may have
been concerned because of scrutiny by the U.S. Federal Trade
Commission who were worried about market dominance of certain
therapeutic areas resulting from the merger.
Whatever the reason for the withdrawal there still is a way
that you may be able to obtain Dutasteride. Glaxo was simultaneously
testing the same drug for both BPH, Benign Prostatic Hyperplasia
and for hair loss. Glaxo did complete Phase 3 trials for the
Prostate version and it is believed that they are in the process
of submitting it to the FDA for approval. This information
was reported by our resident expert Dr Richard Lee:
"I
called Glaxo-Wellcome in regards to dutasteride (GI198745)
and was told that dutasteride has 'just completed' Phase 3
clinical trials and will be submitted to the FDA as an NDA
(New Drug Application) for the treatment of benign prostatic
hyperplasia 'soon'. The spokesperson's estimate as to when
dutasteride would be available as a prescription medication
is '6 to 12 months' hence.
If Dutasteride is available you will be able obtain it if
your physician will write you a prescription for it. As Dr
Lee explains, "The medical profession has always been
accepting of using a drug for purposes other than that for
which it has been approved by the FDA (e.g. taking aspirin
for prevention of heart disease). This practice is referred
to as "off-label prescribing". It was the method
in which I prescribed finasteride before Propecia was available."
We have also heard word that there is a drug company outside
the USA that will be selling a generic Dutasteride as soon
as April 2001. While we don't want to give out any info until
its been validated, we do feel that there is a very good chance
that Dutasteride will be available to some people sometime
in 2001.
This is good news for all hair loss sufferers as Dutasteride
is a lot more effective than Propecia since it eliminates
almost all the DHT produced in the body. We will keep you
informed of the latest news about Dutasteride through the
Hair Loss News Update.
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