November 11, 2002 - Hairlosshelp previously reported the news that Glaxo would be resuming Phase 3 hair loss trials. According to our sources they had already selected the sites for the studies and the trials were scheduled to begin in March 2003.
However late last week we received word that Glaxo has now called off the Phase 3 hair loss trials. This is now the second time that Glaxo has pulled the plug on its Phase 3 hair loss trials.
According to our source, the reason for this is that Glaxo's management does not think that Dutasteride will be able to be sufficiently differentiated from Propecia in the consumers mind to make the drug significantly profitable. We do not have any confirmation from Glaxo as to their reason why they pulled the plug.
Fortunately the U.S. Food and Drug Administration (FDA) has approved Dutasteride, also known as under its brand name Avodart®, for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
This means that hair loss sufferers can still get this drug if its prescribed for off-label purposes by their physicians.
Dutasteride, a second-generation 5 alpha-reductase inhibitor, is the first and only medicine to inhibit both the type 1 and type 2 enzymes responsible for the conversion of testosterone to DHT (dihydrotestosterone), the primary cause of prostate growth. Dutasteride's dual inhibition decreases levels of DHT by 90 percent at two weeks and 93 percent at two years.
According to Glaxo, Dutasteride will be available in pharmacies in December 2002.
For more information about Dutasteride (Avodart®) visit
www.dutasteride.org. />
SITE RESOURCES
Official Dutasteride Fact Sheet
Dutasteride Phase 2 Clinical Trial Results
New Dutasteride Study
OTHER RESOURCES (opens in new window)
Glaxo corporate web site
Merrill Lynch Global Pharmaceutical Investor Conference - September 25, 2001
Lehman Brothers - Dutasteride presentation - October 10, 2001
Bear Stearns HealthCare Conference - September 18, 2002
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