New drug offers oral route for male baldness.
January 19, 1998

Just short of grasping for Rapunzel's luxurious locks, men desperately seeking to halt the inevitable balding process have smeared, smudged, massaged, and shampooed dozens of hair-promising gels, creams, and lotions onto their heads. But until now, they've never popped a pill.

Manufactured by Merck & Co., Propecia (finasteride), 1 mg, is the first oral medication to leap out of the pipeline for the treatment of male pattern hair loss (androgenetic alopecia). But finasteride is already available in a 5-mg strength under the brand name Proscar for the treatment of symptomatic benign prostatic hyperplasia (BPH).

What triggered Merck's entrance into the hair market? "Well, the story goes back a long way to the discovery of males who were born with the absence of 5-alpha-reductase--an enzyme that converts testosterone to the active form, dihydrotestosterone [DHT]," recalled Ronald Savin, M.D., clinical professor of dermatology at Yale University. He said that these isolated individuals--born with ambiguous genitalia that resolved at onset of puberty--never suffered the perils of androgenetic alopecia, prostate swelling, or prostate cancer.

After further research, it was determined that the balding scalp of men with androgenetic alopecia contained increased amounts of DHT, compared to hairy scalps. And since finasteride is a selective type II 5-alpha-reductase inhibitor--acting primarily in the scalp and prostate to prevent DHT formation--its use for the just-approved indication makes sense.

What kind of results can one expect from the product? According to Savin, finasteride's effects vary among individuals, with a greater increase in hair growth noted on the back and top of the scalp than in the front. Men studied were aged 18-41 and had mild to moderate hair loss of the vertex and anterior mid-scalp areas.

In one analysis, an increase in hair growth--evaluated with the use of photographs--was demonstrated in 66% of men receiving a 1-mg tablet of finasteride daily for a period of 24 months, compared with 7% of those given placebo. Diane Thiboutot, M.D., associate professor, division of dermatology, Pennsylvania State University, indicated that clinical improvement in hair PAGE 18 Drug Topics January 19, 1998 density was gradual and began at approximately three months into therapy. Since withdrawal of treatment leads to reversal of effects within 12 months, continued use is recommended.

Perhaps a more substantial benefit is the drug's ability to prevent hair loss. In a 24-month follow-up, 17% of men treated with finasteride experienced hair loss, while 83% had the same or higher hair count. Of those given placebo, 72% lost hair. "It looks like finasteride is a potent stabilizer, and that's a tremendous advantage for men just beginning to go bald," said Savin. As for finasteride's competition, minoxidil, don't be surprised if you see the topical product joining forces with the tablet. Although controlled studies have not been conducted, Savin claimed that a minoxidil/finasteride combo--used in a number of his patients--appears to be more effective in the preservation of the much-treasured strands than either agent alone.

Finasteride's main snag appears to be its adverse-effect profile, which includes a decreased libido, erectile dysfunction, and ejaculation disorder. These effects occurred in less than 2% of men; they resolved in all who discontinued therapy and in 58% of those who continued on the drug. Gene Memoli Jr., R.Ph., director of pharmaceutical care, Value Health Care Services Inc., feels that although these side effects are rare, they are a significant concern, since the drug will be dispensed to a large patient population. And that's not the only worry. Because finasteride undergoes extensive hepatic metabolism, labeling cautions against its use in patients with liver function abnormalities.

Finasteride is contraindicated in women who are, or may be, pregnant due to its potential to cause abnormalities of the external genitalia of a male fetus. To avoid any risk of absorption, these individuals should not handle crushed or broken finasteride tablets. Thiboutot disclosed that finasteride is being evaluated in a pilot study for postmenopausal women suffering from hair loss. She added that if results are favorable, Merck may initiate larger trials.

Memoli believes the drug will be welcomed by the balding population--perhaps too hastily. He urges that patients exhaust other alternatives, including hair weaves and minoxidil, before turning to a systemic drug for cosmetic reasons. Memoli stressed that patients receiving finasteride be adequately monitored by a physician.

Propecia is supplied as 1-mg tablets in unit-of-dose bottles of 30 and in a ProPak carton containing three bottles. The catalogue price to wholesalers and direct purchasers for the product is set to be $ 1.25 per tablet. The estimated retail price for the product is expected to be between $ 45 and $ 49 per month.

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