About 40 million American men are experiencing male pattern baldness. That's the common problem of losing hair as you age, an inherited condition. For ten years, minoxidil marketed as Rogaine, was sold in a solution strength of 2 percent. It was a prescription only drug that grew hair on balding men. Beginning in July 1996, Over-the-counter (OTC) Rogaine became one of the hottest selling things on the Internet.

In January 1998 a new Rogaine was available over-the-counter for the first time and for about half of its original prescription price. Now, after FDA approval, consumers can buy minoxidil in a strength of 5 percent.

Early reports have shown that, some people are ecstatic about Rogaine's results. Mark Dressel, a 28-year-old Philadelphia assistant advertising account executive, has achieved what he called maximum hair regrowth with Rogaine. "Rogaine has given me results beyond what I expected. I started using it just to keep the hair I had but after 8½ months I have substantially more hair that's grown in."

Management at Pharmacia & Upjohn seem to believe their claims that, "Rogaine Extra Strength for Men regrows hair or stops hair loss in 4 out of 5 men."

The drug was originally tested in the early 1980s as a treatment for hypertension, says Pharmacia & Upjohn spokesman John Ruane. Researchers noticed that some of those taking the drug experienced unusual hair growth. Rogaine was born. "We're not exactly sure how it works," admits Ruane. "But it's an amazing, complicated product." One milliliter (ml) of Rogaine, about the amount in a small medicine dropper, is applied to the affected areas of the scalp using an applicator twice daily. Users must keep the scalp dry for four hours after application. Says Ferrara, "It may have something to do with the fact that minoxidil increases blood flow to the scalp. But it's probably some as yet unexplained ingredient or combination of ingredients."

While it is the first US Food and Drug Administration approved medication of its kind, Rogaine doesn't work for all types of hair loss. Pharmacia & Upjohn Inc., the manufacturer and marketer of the drug, emphasizes that Rogaine is only for patients with common hereditary hair loss, also known as androgenetic alopecia or male pattern baldness, along the center line of the scalp. The package cautions that the amount of regrowth is different for each person and that Rogaine, "will not work for everyone." The company's studies claim that after four months of treatment with the original 2 percent solution, 26 percent of men reported moderate to dense regrowth. Only 19 percent of women reported the same in a separate clinical trial. Optimum results were achieved after a year of applications. Those men using the newer 5 percent "extra strength" version saw results which were faster and more dramatic.

In 1997 Pharmacia & Upjohn presented results from clinical studies to the FDA's Non-prescription Drugs Advisory Committee and also to the Dermatologic and Ophthalmic Drugs Advisory Committee showing that Rogaine Extra Strength for Men will grow up to 46% more hair for men than regular strength Rogaine, with the onset of hair regrowth occurring at eight weeks compared to the regular strength Rogaine which begins regrowing hair at 16 weeks. The two advisory committees concluded that while Rogaine Extra Strength for Men may, in fact, be used by some women, its availability in the marketplace would not pose a health risk for them. The main side effect of Rogaine Extra Strength for Men, irritation of the scalp, was reported by some patients in clinical studies. Irritation of the scalp (itching and dryness) is the most common side effect associated with regular strength Rogaine as well.

Outside the United States, Rogaine Extra Strength for Men is marketed to both men and women under the brand name "Regaine 5" in 14 countries, including two countries as a non-prescription product. The first country to receive approval was New Zealand in 1993. Pharmacia & Upjohn researchers are continuing work with the FDA on the Rogaine Extra Strength product for women, targeting it for over-the-counter clearance in the near future.