Breaking News in Urology

December 27, 1997

FDA Approves Pill for Male Pattern Baldness

Adapted from an original New York Times article by Sheryl Gay Stolberg -- December 23, 1997

WASHINGTON, DC-- The Food and Drug Administration announced yesterday that it had given Merck & Co., the giant pharmaceutical firm, permission to sell a tablet that, in clinical trials, either promoted the growth of hair or at least stopped hair loss in 83 percent of men who took it. The medication is Propecia, and its active ingredient is finasteride. [USRF has been involved in finasteride research for more than five years testing the drug in its Proscar form for benign prostatic hyperplasia . Part of the USRF Proscar research project was published earlier this year in the Journal of Urology.]

An estimated 33 million American men have male pattern baldness, characterized by a receding hair line and hair loss at the vertex, or crown, of the scalp. One survey, published four years ago in a dermatology journal, found that more than 90 percent of men who were growing bald worried about the future of their hair. "One man's frivolity," said Dr. Michael Weintraub, the director of the FDA office that evaluated Propecia, "is another man's serious problem."

Merck conducted three clinical trials of Propecia, involving 1,879 men, 1,215 of whom were followed for as long as two years. Although Merck scientists studied men who had a wide range of hair loss, the experiments enrolled only men from the age of 18 to 41. Thus there are no data on how Propecia works in older men.

None of the men in the studies grew back a full head of hair. But when scientists counted the number of hairs in a one-inch-dimater circle on the scalps of the subjects, they found that 83 percent of the men had kept their hair or grown more.

And before-and-after photographs, which Merck submitted to dermatologists for evaluation, showed visible improvements in two-thirds of the men taking the pill, as against 7 percent of men taking a placebo.

The only side effects related to sexual function. According to Merck, 1.8 percent of the men taking Propecia experienced decreased libido; 1.3 percent had difficulty achieving an erection, and 1.2 percent reported a decrease in their semen level. The problems went away, however, when the men discontinued use. Propecia contains 1 mg of finasteride, Proscar 5 mg.

Merck officials said they expected that Propecia, which is to be available in pharmacies next month (late January, 1998), would cost $45 to $49 a month.



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