Pharmacia & Upjohn Rogaine Extra Strength introduction slated for mid-December.

PHARMACIA & UPJOHN ROGAINE EXTRA STRENGTH EXCLUSIVITY AWARD LIKELY in light of the new clinical trials the company conducted for its NDA for the OTC sale of 5% minoxidil solution hair regrowth treatment. Marketing exclusivity for the stronger Rogaine product would provide Pharmacia & Upjohn an advantage the company did not receive for the switch of the original 2% minoxidil Rogaine. The extra strength version of the antibaldness treatment will be on store shelves around Dec. 16, P&U said Nov. 17.

The NDA (20-834) for the stronger formulation of minoxidil solution received FDA approval Nov. 14 for treatment of hereditary male pattern baldness, adding to the list of over-the-counter products marketed under NDAs that have leapfrogged the Rx marketing phase. Regular strength Rogaine, approved for OTC use for men in 1996, contains 2% minoxidil. Pharmacia & Upjohn submitted the NDA for OTC Rogaine Extra Strength in February after submitting an NDA for Rx status in December 1995.

The denial of marketing exclusivity by FDA following the February 1996 OTC approval of Rogaine 2% minoxidil cleared the way for a slew of generic versions of Rogaine. The denial of exclusivity also prompted the company to file a lawsuit against FDA, as well as the issuance of a restraining order against companies that wanted to introduce private label versions of the drug.

In an April 30, 1996 decision, a federal court ruled that a consumer use study P&U conducted for Rogaine, although new, was not essential for the switch of the product; the Rogaine data must be new and essential for the product to be awarded three years of Waxman/Hatch exclusivity.

Rogaine Extra Strength clinical trial data showed a 48% increase in hair growth at 48 weeks. At its July 16 consideration of the NDA for Rogaine Extra Strength, FDA's Nonprescription Drugs Advisory Committee agreed that faster hair growth claims would be unsubstantiated because faster regrowth was not a primary endpoint of the trial in which the pattern was observed ("The Tan Sheet" July 21, pp. 3-6). FDA Office of Drug Evaluation V Director Michael Weintraub, MD, expressed confidence at the meeting that inclusion in the label of the onset of effect could be worked out with P&U.

Packaging makes clear the product is not for use by women, as recommended by the committee. A separate 5% minoxidil product for women is being pursued by Pharmacia & Upjohn, which has clinicals under way for the indication. Clinicals conducted thus far have not shown statistically significant effects in women, according to P&U.

The advisory committee members acknowledged that Rogaine Extra Strength likely will be purchased by some women, but they felt the potential health risk to be acceptable. The most frequently reported adverse events seen with use of Rogaine Extra Strength in the P&U safety data were dermatological in nature, including itching, erythema and dryness, although there also were reported incidences of tachycardia, or rapid heart beat.

The package insert for the stronger product states that it differs from the 2% minoxidil product in that it "regrows more hair" and "with Rogaine Extra Strength For Men, results may occur at two months with twice-daily use. For some men, it may take at least four months for results to be seen." The leaflet adds that 5% minoxidil "is more likely to cause scalp irritation" than 2% minoxidil. The insert warns: "If scalp irritation continues or worsens, stop use and see a doctor."

The insert notes that "Women should not use Rogaine Extra Strength because studies have shown it works no better in women than Rogaine for Women. Some women may also grow facial hair. In addition, Rogaine Extra Strength may be harmful if used during pregnancy or breast-feeding." The insert and labeling are otherwise similar to those for 2% minoxidil products.