Procter-Syntex to launch Femstat 3 OTC yeast infection cream this spring.

PROCTER-SYNTEX' FEMSTAT 3 THREE-DAY OTC YEAST INFECTION CREAM TO LAUNCH in early spring, following FDA's Dec. 21 approval of an Rx-to-OTC switch application for the product. The butoconazole nitrate 2% cream is indicated for the local treatment of vaginal yeast infections. Procter-Syntex touted the product's status as the only three-day vaginal yeast infection treatment to be cleared for OTC marketing in a Dec. 27 release on the approval.

Johnson & Johnson's Monistat 7, Schering-Plough's Gyne-Lotrimin, and Bayer's Mycelex 7 are seven-day regimens. The advantage of the three-day regimen may also help Procter-Syntex lure consumers away from seven-day treatments marketed under lower-priced private labels.

J&J markets a three-day prescription version of Monistat called Monistat 3 but the company would not comment on plans to switch the product. Monistat 3 headed a list of "most likely" switches released in May by Kline & Co. Healthcare Practice. The list was based on a survey of 230 physicians, 200 pharmacists and 500 consumers ("The Tan Sheet" May 22, pp. 5-6).

Femstat 3 has been awarded three years of market exclusivity, a first among the vaginal yeast infection switches. The product is the seventh Rx-to-OTC switch application to be approved in 1995.

Clinical studies conducted in support of the Femstat 3 switch involved over 300 patients and demonstrated, according to Procter-Syntex, that "the three-day regimen with butoconazole nitrite 2%...was as safe and effective as the 7-day regimen of miconazole nitrate 2% cream (Monistat 7) for the treatment of vulvovaginal candidiasis when evaluated at eight and 30 days post-treatment."

The company also relied on data that established the efficacy of prescription Femstat. The data were collected from studies involving over 1,300 patients, about 900 of whom received butaconazole nitrate 2% treatment.

Because their sponsors did not conduct new clinical trials in support of the switch applications, neither Monistat 7 nor Gyne-Lotrimin was awarded exclusivity. Following an initial period of explosive growth, the brand name products have lost substantial share to private label products subsequently entering the market.

Femstat 3 will be the second product to reach the market from the Procter-Syntex joint venture. The product follows the naproxen sodium switch Aleve, which was launched in June 1994. The $100 mil. introduction of Aleve showcased Procter & Gamble's marketing muscle and has helped to set a benchmark for big switch launches.

Formation of the 50-50 joint-venture agreement was announced in March 1988 by Procter & Gamble and Syntex Laboratories, which was purchased by the Swiss company Roche Holding Ltd. in 1994. Roche will manufacture Femstat 3; Procter & Gamble will handle marketing and distribution to pharmacies, drug stores, supermarkets and mass merchandise outlets.

Consumer advertising for the product has been assigned to Chicago-based Leo Burnett, which also handles Procter & Gamble's Pepto-Bismol account. Foote Cone Belding Healthcare in New York will handle professional advertising for the product. Femstat 3 will be marketed in packages of three five-gram prefilled disposable applicators and in a 20-gram tube with three non-prefilled disposable applicators. Recommended dosage is one applicator of cream each day for three consecutive days.

Detailing the product's instructions for use, Procter-Syntex said: "Femstat 3 should be used vaginally by nonpregnant women and girls age 12 and over for three consecutive days, preferably at bedtime. If a woman is pregnant, or suspects she may be, it is recommended that she consult her physician before using Femstat 3 or any other vaginal anti-fungal product."

The company also listed the product's safety precautions, including the admonition that "first-time sufferers should see a doctor. Femstat 3 should not be used if experiencing abdominal pain, fever, or foul-smelling discharge." The precautions also warn that "if symptoms return within two months or if women think they have been exposed to the HIV virus that causes AIDS, a doctor should be called immediately"; "this product may damage condoms and diaphragms and may cause them to fail"; "Femstat 3 should not be used with tampons"; and "this product should not be used in girls under 12 years of age."

The agency's approval of Femstat 3 marks the first time a switch NDA has been approved without an advisory committee review since the establishment of the Nonprescription Drugs Advisory Committee in 1992. Procter-Syntex initially filed the NDA December 17, 1993; the application was resubmitted August 31, 1995.