Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - 12 May 1997.
One-Dose Convenience and Patient Compliance
VAGISTAT-1 provides a complete course of treatment for most vaginal yeast infections in one dose. Its ointment formulation and pre-filled applicator make the product 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.(a)
A recently published article authored by Sebastian Faro, M.D. in The Female Patient supports the benefits of single-dose topical therapy, such as tioconazole. This article notes that topical azoles are the first line therapy for treatment of vaginal yeast infections achieving mycologic and clinical cures with minimal systemic effects.(b) The article also explains that compliance can be enhanced by choosing a single-dose regimen for patient convenience.
"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, Ill. "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."
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.(c) 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.
Excellent Safety and Efficacy Profiles
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)
The safety and efficacy profiles of VAGISTAT-1 are well established and similar to that of Monistat(R) 7,* a seven-day OTC treatment.(e) 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.
No Known Drug Interactions
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) 150mg),** an oral prescription medication that has the potential to cause drug interactions with several commonly used medications (e.g., theophylline, oral hypoglycemics), as well as some widely proscribed oral contraceptives.(f)
As with most vaginal antifungals, 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 Company (NYSE: BMY) received U.S. Food and Drug Administration clearance to market VAGISTAT-1 as an over-the-counter treatment for vaginal yeast infections in February 1997. The retail price for VAGISTAT-1 ranges from $13.99 to $15.99. A toll-free number provides a service to consumers and health care professionals who have questions regarding VAGISTAT-1. The number is 1-888-VAGISTAT.
VAGISTAT-1 is the first switch of a Bristol-Myers Squibb prescription product to OTC status. Annual sales in the U.S. vaginal yeast infection category in 1996 were approximately $275 million.
Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. 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) is a registered trademark of Johnson & Johnson.
** Diflucan(R) is a registered trademark of Pfizer Inc.
(a) 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.
(b) Faro, S, Apuzzio, J, Bohannon, N, et al. Treatment Considerations in Vulvovaginal Candidiasis. The Female Patient. 1997;22.
(c) Faro, S. Systemic vs. topical therapy for the treatment of vulvovaginal candidiasis. Infectious Diseases in Obstetrics and Gynecology 1994;1:202-208.
(d) The clinical significance of in vitro data is not known.
(e) Data on file, Brystol-Myers Squibb Company.
(f) Some oral contraceptive blood levels may be affected by Diflucan.
CONTACT: Melissa Nachman of Ruder-Finn, 212-593-5893, for Brystol-Myers Squibb/
Copyright (c) 1997/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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