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| |  OTC VAGISTAT-1 Treatment for Vaginal Yeast Infections Cleared by FDA NEW YORK, Feb. 12, 1997 -- Bristol-Myers Squibb Company (NYSE: BMY) announced today that it has received U.S. Food and Drug Administration clearance to market VAGISTAT(R)-1 (tioconazole 6.5%) vaginal ointment as an over-the-counter (OTC) treatment for vaginal yeast infections. VAGISTAT-1 is the first and only one-dose medication for vaginal yeast infections approved for use without a prescription. All other OTC medications for vaginal yeast infections require three or seven days of treatment. Approximately 75% of all women will have a vaginal yeast infection at least once in their lifetime. Of these women, about half will have a recurrence.(a) All OTC yeast infection products are intended for use by women who have had a physician diagnose this condition before and are experiencing the same symptoms again. First-time sufferers are advised to consult a physician. One-Dose Convenience and Patient Compliance VAGISTAT-1 provides a complete course of treatment for most vaginal yeast infections in one dose. The ointment formulation and pre-filled applicator make VAGISTAT-1 easy to use and more convenient than multidose cream medications. Most women feel some relief of symptoms within one day of application of VAGISTAT-1 and experience complete relief within seven days. Among patients who used VAGISTAT-1 in a clinical study, satisfaction was high: 99% of patients found the product convenient to use and 92% would use it again.(b) "There is a strong link between convenience and patient compliance," said Sebastian Faro, M.D., Ph.D., John M. Simpson Professor and Chairman, Department of Obstetrics and Gynecology, Rush Medical College, Chicago, IL. "With three- or seven-dose vaginal yeast infection treatments, many women stop using the medication when their uncomfortable symptoms subside. But, by not taking the full course as directed, an infection may persist or recur. VAGISTAT-1 is a simple, one-dose formula that ensures a woman will receive the full course of therapy she needs for effective treatment." VAGISTAT-1 is the first switch of a Bristol-Myers Squibb prescription product to OTC status. It will be available shortly in drug and food stores as well as mass merchandise outlets nationwide. Annual sales in the vaginal yeast infection category in 1996 were approximately $275 million. "The approval of VAGISTAT-1 is a major advance for women in this country," said Sion Boney, president, Bristol-Myers Products, the U.S. consumer products division of Bristol-Myers Squibb Company. "By making this highly convenient and effective medication available without a prescription, Bristol-Myers Squibb is empowering women to take better care of their own health." Excellent Safety and Efficacy Profiles The safety and efficacy profiles of VAGISTAT-1 are well established and similar to that of Monistat(R) 7,* a seven-day OTC treatment.(c) A low incidence of adverse reactions to VAGISTAT-1 was found in clinical trials involving 1,060 patients with vaginal yeast infections. The most frequent side effects were burning and itching, which occurred in approximately 6% and 5% of the patients, respectively; these are also the most common symptoms of the condition itself. The active ingredient in VAGISTAT-1 is tioconazole, a broad-spectrum antifungal agent that inhibits the growth of vaginal yeasts. In vitro studies have shown that tioconazole is effective against a wide range of pathogens that cause vaginal yeast infections.(d) VAGISTAT-1 is a topical (vaginal) preparation with no known drug interactions. The only other one-dose treatment for vaginal yeast infections is fluconazole (Diflucan(R)),** an oral presciption medication that has the potential to cause drug interactions with several commonly used medications (e.g. theophylline, oral hypoglycemics), as well as some widely prescribed oral contraceptives. The VAGISTAT-1 ointment base may interact with rubber or latex products such as condoms or vaginal contraceptive diaphragms, therefore, women should avoid using such products for three days following treatment. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical device. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. Visit Bristol-Myers Squibb on the World Wide Web at http://www.bms.com. * Monistat(R) 7 is a registered trademark of Ortho Pharmaceutical Corporation. ** Diflucan(R) is a registered trademark of Pfizer Inc. (a) Faro S. Systemic vs. topical therapy for the treatment of vulvovaginal candidiasis. Infectious Diseases in Obstetrics and Gynecology 1994; l:202-208. (b) Clark C, Cooper CL, Gordon SF, van Amerongen D, Smith FO, Upmalis DH. A multicenter comparison of one-dose tioconazole ointment with three-dose terconazole cream in vulvovaginal candidiasis. Journal of Women's Health. 1993; 2:189-196. (c) Data on file, Bristol-Myers Squibb Company. (d) The clinical significance of in vitro data is not known.
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