Women with thinning hair now have over-the-counter access to a higher-powered Rogaine formula in the U.S., where regulatory restrictions afford few OTC drug, let alone cosmetic, treatment options.

Johnson & Johnson subsidiary McNeil-PPC Inc. touts new Women’s Rogaine topical aerosol (foam) with 5% minoxidil as “a welcome solution to women looking for a proven solution to treat the condition rather than a cosmetic, quick fix.”

The product’s market introduction follows FDA’s approval in February of the Johnson & Johnson subsidiary’s supplemental new drug application, which built on the 2006 NDA approved for over-the-counter use of Extra Strength Men’s Rogaine topical aerosol with the same minoxidil concentration.

The women’s product is indicated for once-daily use to treat female-pattern hair loss on the top of the scalp.

According to FDA’s Orange Book database, McNeil has market exclusivity for Women’s Rogaine with 5% minoxidil through February 2017.

“Unlike cosmetic thickeners which coat the hair and temporarily mask the issue, this innovative product when used once a day, every day, actually helps regrow hair.” - New York dermatologist and brand consultant Doris Day

FDA green-lighted the first Rogaine products for OTC use – 2% and 5% topical solutions – in 1996 and 1997, respectively, though approval for the higher concentration was limited to men consistent with testing submitted in support of the application.

Minoxidil can have an androgen effect, mimicking male hormones. To date, the 5% solution has been available only off-label for women who meet doctors’ prescription criteria.

However, recent studies by McNeil showed the topical aerosol safely regrew hair in 81% of women who used the product daily in a six-month clinical study.

According to McNeil, subjects randomized to the product (versus placebo) experienced hair regrowth as early as 12 weeks into the study. Further, hair-strand diameter measurements found that hair becomes 48% thicker when the product is used once a day, the firm reported in an Oct. 15 release.

“Unlike cosmetic thickeners which coat the hair and temporarily mask the issue, this innovative product when used once a day, every day, actually helps regrow hair,” says New York dermatologist Doris Day, who is consulting with McNeil on the launch.

Women’s Rogaine with a higher minoxidil concentration was approved via a supplemental new drug application building on the 2006 NDA that FDA approved for Extra Strength Men’s Rogaine topical aerosol with a 5% formula.

The formula is designed to fit “seamlessly into any beauty routine, akin to moisturizing or using an eye cream,” the firm says, noting women can spray it onto hair and rub it into roots. The product’s “biodelivery” system is designed to break down with body heat to deposit active ingredients on the scalp without residue, making styling much easier, according to McNeil.

Minoxidil is minimally contested in the U.S. hair-loss treatment space as the only FDA-approved ingredient for hair regrowth. Finasteride (Propecia) also is FDA-approved, but for preventing hair loss, not spurring hair growth, and it is indicated solely for use by men.

The new Women's Rogaine 5% minoxidil foam sells on the brand’s website for $29.99 for a two-month supply, or $49.99 for a four-month supply.

J&J could use a boost in its consumer health-care segment after sales fell below analysts’ expectations in the firm’s fiscal 2014 third quarter even as its OTC drug market share grew in the U.S. due to retailers adding seasonal product inventory and restocking the firm’s recalled brands ([A#02141020007]).

Worldwide consumer sales fell 0.6% to $3.6 billion, about $40 million lower than investment analysts expected. U.S. consumer sales took the biggest hit, dropping 4.2% compared with the year-ago period to $1.17 billion.

Minoxidil Benefits Not Without Risks

While minoxidil holds promise for women suffering from hair loss, experts note that androgen-related side effects could be of concern.

Minoxidil is safe, but its use carries a risk of hypertrichosis, “excessive hair growth in the wrong places, such as the cheeks or forehead,” according to a Harvard Medical School article on treating female hair loss, which notes that “this problem is more likely with the stronger 5% solution.”

Facial hair growth can occur if minoxidil drips down onto a user’s face, or manifest as a side effect even when the ingredient only comes in contact with a user’s scalp.

Additionally, minoxidil users occasionally report that “new hair differs in color and texture from surrounding hair,” and some women find the solution leaves a deposit that dries and irritates their scalp. The irritation, or contact dermatitis, probably is caused not by minoxidil but rather by the alcohol included in the formulation to facilitate drying, the Harvard Medical article indicates.

Labels for Extra Strength Men’s Rogaine with 5% minoxidil and for Women’s Rogaine with the higher concentration are similar, according to the National Institutes of Health’s National Library of Medicine. Among differences is that the men’s offering is indicated for twice-daily use.

The Women’s Rogaine label warns against use when pregnant or breast-feeding and refers to a booklet included in the package for complete directions on use.

Hair-Loss Market Not Thinning

Women’s Rogaine, distributed by McNeil’s Skillman, N.J.-based Johnson & Johnson Healthcare Products Division, has a potentially massive target demographic as one in three women notice hair thinning in their lifetime, and that loss often starts in puberty, according to the firm.

McNeil consultant Day says losing 50 to 100 hairs daily is normal for men and women, but people who consistently shed 150 or more hairs may be experiencing significant loss.

Indeed, the American Academy of Dermatology estimates that 30 million women in the U.S. experience hereditary-related hair loss, though many also experience loss from vitamin depletion and stress. Demand for hair-thickening and regrowth products is challenging the cosmetics industry to innovate and provide solutions.

Japanese firm Shiseido is among the major beauty firms working on products that address thinning hair, pursuing its own clinical research on baldness and associated product development after signing an agreement with RepliCel Life Sciences Inc., a Toronto-based firm focused on the development of autologous cell therapies to address pattern baldness and aging skin, among other conditions.

Under the agreement, Shiseido has exclusive licensing rights for the firm’s hair regenerative technology RCH-01 in Asian countries including Japan, China, Taiwan and South Korea. Shiseido paid RepliCel approximately $3.5 million upfront and also agreed to sales milestone payments of roughly $27.8 million, plus royalties. Shiseido has not disclosed its plans for timing of any launches that come from the research.

According to RepliCel, RCH-01 is a patented cellular replication and implantation technology designed to rejuvenate damaged and miniaturized hair follicles in balding scalp.”

In the U.S., firms must be careful not to run afoul of FDA regulations, for example with claims that identify cosmetic hair-health products as drugs in the agency’s eyes Also see "Dermocosmetic Market Ripens With Uptake Of FDA-Approved Drug Ingredients" - HBW Insight, 4 September, 2014.

Procter & Gamble Co.’s Pantene brand markets a 2% minoxidil Hair Regrowth Treatment for Women under its Expert Collection, priced at $23.99 for a one-month supply. The line also includes Age Defy and Advanced Keratin Repair hair-care items.

L’Oreal SA has developed a proprietary molecule called Stemoxydine, which according to the company “imitates the optimal environment of stem cells in hair follicles, revitalizing hair that has become dormant.”

The ingredient figures in Kerastase Densifique products and the VichyNeogenic range, available in markets outside the U.S.

The Kerastase Densifique line is available to American consumers, though the brand’s U.S. website does not list Stemoxydine among key ingredients and features marketing claims limited to “add[ed] body without weight” and “improvement in hair’s texture, shine and suppleness.”

In other markets around the globe, the L’Oreal brand highlights Stemoxydine’s ability to “create visible hair mass,” yield “1,700 new hairs in three months” and “significantly increase the amount of hair per sq. cm.”

Approaching anti-aging hair care from another angle, the L’Oreal Paris Advanced Haircare line, launched in January 2013, includes a Triple Resist range that can reduce “hair fall” due to breakage by 64%, the brand says Also see "Insiders’ 2014 Forecast: Anti-Aging Hair Care To Drive Innovation" - HBW Insight, 9 December, 2013..

With its Nexxus Youth Renewal line, Unilever PLC is another major player to tap the growing anti-aging hair-care trend. The collection is designed to address eight signs of aging hair – volume loss, breakage, roughness, dullness, dryness, brittleness, unruliness and loss of color vibrancy.

J&J Pits 5% Minoxidil Rogaine For Women Against ‘Cosmetic, Quick Fixes’

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