FDA Approves PROSCAR® Combined With Doxazosin to Reduce the Risk of Benign Prostatic Hyperplasia Symptoms

Merck & Co., Inc. today announced that the Food and Drug Administration (FDA) has approved changes to the prescribing information for PROSCAR® (finasteride) based on a landmark National Institutes of Health (NIH) study.  Now, PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of the symptoms of benign prostatic hyperplasia (BPH), or benign enlargement of the prostate, from progressing over time (a confirmed rise of four or more points in AUA symptom score). 

Benign prostatic hyperplasia is a common condition that occurs in more than 50 percent of men between the ages of 51 and 60 and up to 90 percent of men over the age of 90.  Benign prostatic hyperplasia can block the flow of urine through the urethra and may cause symptoms, such as slow urinary stream, straining to urinate, frequent urination, nighttime urination and an urgency to urinate.

The new indication is based on the Medical Therapy of Prostatic Symptoms (MTOPS) study published in December 2003 in The New England Journal of Medicine.  In this 3,047-patient study, PROSCAR combined with doxazosin significantly reduced the risk of BPH symptoms progressing when compared to placebo and to either PROSCAR or doxazosin alone.

“Before now, I commonly treated men first diagnosed with BPH with an alpha-blocker, such as doxazosin.  Today, for the first time, the FDA has approved combination therapy with finasteride and doxazosin,” said Steven Kaplan, M.D, vice chairman, Department of Urology at Columbia University Medical Center, and MTOPS study investigator.  “Finasteride when combined with doxazosin has been shown to reduce the risk of BPH symptoms getting worse.  In my own practice, I plan to use more combination therapy to treat men with symptoms of BPH.”