Hair Loss Issues
GSK is believed to have entered Phase III trials with Dutasteride for hair loss. Their Supplemental New Drug Application for hair loss is thought to have been submitted to the FDA sometime in 2001. Avodart™ appears to have a much greater and longer inhibition of DHT than Propecia (Finasteride) in the early testing phases. Is it better than Propecia, and are its side effects greater or more serious? These are questions that are unanswered at this time – but time will tell. It’s currently approved in a 0.5 mg softgel form.
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 has been found to decrease levels of DHT by 90 percent at two weeks and 93 percent at two years.By reducing DHT levels, dutasteride reduces the size of an enlarged prostate. This reduction in prostate volume was seen as early as one month with reductions continuing through treatment. Shrinking the enlarged prostate is beneficial for relieving urinary obstruction and improving urinary flow. While improving urinary symptoms Dutasteride also reduces the risk of AUR (the sudden complete inability to urinate), and BPH-related surgery, which are two potential long-term serious consequences of BPH. The pivotal phase III study data were published in this month’s edition of the journal Urology.”With dutasteride, we now have a medicine that reduces the production of DHT by more than 90 percent, helping to shrink the prostate,” said Claus Roehrborn, MD, a principal trial investigator and professor and chairman of the Department of Urology at the University of Texas Southwestern Medical Center in Dallas , Texas . “By taking dutasteride, patients can improve urinary symptoms and reduce their risk of suffering from acute urinary retention - where you suddenly can’t urinate at all - or needing BPH-related prostate surgery.”AvolveÒ , Sweden ’s trade name for Dutasteride, was approved by the Swedish regulatory authority (MPA) on July 24th 2002 . The MPA agreed to act as the Reference Member State for the Mutual Recognition procedure within Europe and GSK plans to market the drug in all major European markets once approvals are finalized during 2003. The European trade name (Avolve) is still to be confirmed.