To: Ed Ajootian who wrote (4270 ) 3/13/2000 2:13:00 PM From: Biomaven Read Replies (3) | Respond to of 10280
Cardura Phase I trials launched:Headline: Sepracor Initiates Benign Prostatic Hyperplasia Trial =========================================================== Company to Develop (S)-doxazosin MARLBOROUGH, Mass., March 13 /PRNewswire/ -- Sepracor Inc. (NASDAQ:SEPR) announced today that it has initiated a Phase I clinical study of (S)- doxazosin for the treatment of benign prostatic hyperplasia (BPH). (S)- Doxazosin is a single-isomer form of Pfizer's CARDURA(R). Preclinical studies suggest that (S)-doxazosin binds preferentially to prostate tissue as compared to peripheral blood vessels. Benign prostatic hyperplasia, which is enlargement of the prostate, is a condition common among men over 50 years of age. Sepracor's Phase I clinical studies are designed to evaluate a potential reduction in effects of (S)-doxazosin on blood pressure as compared to racemic doxazosin. Lowered blood pressure can result in severe dizziness and fainting, and (S)-doxazosin has the potential to decrease this side effect. "The presence of hypotensive side effects forces titration, which can lead to multiple visits to the physician's office. It is our belief that (S)- doxazosin can potentially reduce the number of office visits needed to titrate patients, which could result in better patient compliance. Also, the compound may exhibit increased efficacy," stated Paul D. Rubin, M.D., Executive Vice President, Drug Development and ICE Research at Sepracor. In 1999, over $1 billion was spent on drug therapies to relieve common symptoms associated with an enlarged prostate. Though the prostate continues to grow during most of a man's life, the enlargement doesn't usually cause problems until later in life. According to the National Institutes of Health, BPH rarely causes symptoms before the age of 40, but more than half of all men in their sixties and as many as 90 percent in their seventies and eighties have some symptoms of BPH. Cardura is an $800m drug, with a patent about to expire. It very recently got some bad press for its use in hypertension, where it was shown to be worse than diuretics. That study may actually fuel the use of the SEPR ICE version. (It's not clear what proportion of its current sales are for BPH rather than hypertension). SEPR has a planned launch of this ICE in 2003. Peter