To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Vagistat-1, First One-Dose OTC Yeast Infection Treatment Now Available URL: http://www.pslgroup.com/dg/25F86.htm Doctor's Guide May 12, 1997
NEW YORK, May 12, 1997 -- Vagistat-1(R) (tioconazole 6.5%) vaginal ointment, the first and only one-dose, over-the-counter (OTC) medication for vaginal yeast infections, is now available in drug and food stores as well as mass merchandise outlets nationwide. 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 published in 1993 in the Journal of Women's Health, satisfaction was high: 99% of patients found the product convenient to use and 92% would use it again. A recently published article 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. 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, according to a stury published in 1994 in the journal Infectious Diseases in Obstetrics and Gynecology. Of these women, about half will have a recurrence. 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, although the clinical significance of the in vitro data is not known. The safety and efficacy profiles of Vagistat-1 are well established and similar to that of Monistat(R) 7 (Johnson & Johnson), a seven-day OTC treatment (Data on file, Bristol-Myers Squibb Company). 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 Diflucan(R) 150mg (Pfizer Inc.), 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 prescribed oral contraceptives 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 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. 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. 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 maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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