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| |  FDA Approves Cleocin For Bacterial Vaginosis BRIDGEWATER, NJ -- Aug. 16, 1999 -- The United States Food and Drug Administration has approved Pharmacia & Upjohn’s prescription antibiotic, Cleocin(R) (clindamycin phosphate) Vaginal Ovules, for the three-day treatment of bacterial vaginosis in non-pregnant women. Bacterial vaginosis is the most common type of vaginitis among women in the U.S. Administered once-daily, Cleocin Vaginal Ovules are formulated as vaginal suppositories and had similar efficacy in treating bacterial vaginosis as seven-day, twice-daily oral Flagyl(R) (metronidazole) in one controlled study. Cleocin Vaginal Cream has been available by prescription in the U.S. as a treatment for bacterial vaginosis since 1992, first as a seven-day treatment and, later, a three-day treatment option was added. The new ovule formulation is a convenient three-day treatment option for non-pregnant women with bacterial vaginosis. Each Cleocin Vaginal Ovule is a solid, oval-shaped suppository. Bacterial vaginosis is found in 40 percent of women visiting gynecology clinics in the U.S. Symptoms may include a thin, greyish discharge with a foul-smelling odour, especially after intercourse. Bacterial vaginosis is the result of an overgrowth of disease-causing bacteria in the vagina caused by a disruption of the vaginal environment. This disruption can be attributed to a number of factors including douching and sexual relations. The goal in treating bacterial vaginosis is to reduce the number of pathogenic bacteria in the vagina, allowing the normal bacteria to flourish. The FDA approval of Cleocin Vaginal Ovules for bacterial vaginosis was based on the results of three clinical studies that showed use of once-daily Cleocin Vaginal Ovules are effective in treating bacterial vaginosis. These studies include a supportive, placebo-controlled, Phase II study conducted in the U.S. and two well-controlled, international Phase III studies. All three studies were multicentre, randomised, evaluator- or double-blind trials, using 100-mg clindamycin ovules versus a placebo, oral metronidazole or Cleocin Vaginal Cream. Studies involved non-pregnant women 16 to 60 years old who were free of other vaginal infections. The results of these three clinical trials demonstrated superiority of Cleocin Vaginal Ovules treatment over placebo in the Phase II study, comparable efficacy of Cleocin Vaginal Ovules to seven-day treatment with oral metronidazole in one of the Phase III studies, and comparable efficacy of Cleocin Vaginal Ovules to Cleocin Vaginal Cream in the second Phase III study. During the trials, frequencies of side effects, as reported by one percent or more of patients treated with Cleocin Vaginal Ovules, included: vulvovaginal disorder (3.4 percent), vaginal pain (1.9 percent), vaginal moniliasis (1.5 percent) and fungal infection (one percent). Cleocin Vaginal Ovules are contraindicated in women allergic to clindamycin, lincomycin or to the suppository base and in patients with a history of regional enteritis, ulcerative colitis or antibiotic-associated colitis. The safety and efficacy of the product has not been studied in pregnant women.
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