FDA Clears Propecia For Treatment Of Hair Loss In Men

The United States Food and Drug Administration has granted marketing clearance to Merck & Co., Inc.’s Propecia(TM) (finasteride 1 mg), the first and only pill to treat male pattern hair loss (androgenetic alopecia), for use in men only.
Propecia will be available by prescription only and should be on pharmacy shelves by mid-January.

The marketing clearance of Propecia is based on data from three one-year, double-blind, placebo-controlled, multicenter clinical trials involving 1,879 men aged 18 to 41 with mild to moderate hair loss of the vertex and anterior mid-scalp areas. In addition, 1,215 of the men who had hair loss at the vertex, or top of the head, were studied for another year.

Hair count increased during the first year and was maintained in those men taking Propecia for 24 months. Men in the placebo group continued to show progressive hair loss. In an analysis of the men who were followed for up to two years, only 17 percent of men treated with Propecia demonstrated hair loss (defined as any decrease in hair count from baseline); 83 percent had the same or higher hair count. In contrast, 72 percent of the placebo group lost hair, as measured by hair count.

Through questionnaires, all patients were asked to evaluate their response to treatment. Those on Propecia reported an increase in the amount of hair, a decrease in hair loss and improvement in appearance. Clinical improvement was seen as early as three months.

In another analysis, a panel of independent dermatologists evaluated photos in 508 patients after 24 months of treatment. An increase in hair growth was demonstrated in 66 percent of men treated with Propecia compared to seven percent of men treated with placebo. Efficacy in bitemporal recession has
not been established. All men, whether receiving Propecia or placebo, were given a medicated shampoo (Neutrogena T/Gel Shampoo).

“Propecia works by inhibiting the conversion of testosterone to DHT (dihydro-testosterone),” said Keith Kaufman, M.D., senior director of clinical research at Merck Research Laboratories in Rahway, N.J. “It is the first treatment to target this key factor in the development of androgenetic alopecia in those patients genetically predisposed.”

Propecia is for use by men only. It is not for use in women or children. Women must not use Propecia when they are or may potentially be pregnant because it may cause abnormalities of the male baby’s sex organs, a condition known as hypospadias. In addition, women should not handle crushed or broken tablets when they are pregnant or may potentially be pregnant. Propecia tablets have a coating that will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.

In clinical studies, side effects were uncommon and did not affect most men. A small number of men reported less desire for sex, difficulty in achieving an erection and/or a decrease in the amount of semen. Each of these effects occurred in less than two percent of men. These side effects went away in all men who discontinued therapy because of them and also disappeared in 58 percent of men who chose to continue taking Propecia.