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CURATEK ANNOUNCES FDA APPROVAL OF NEW THERAPY FOR BACTERIAL VAGINOSIS

CURATEK ANNOUNCES FDA APPROVAL OF NEW THERAPY FOR BACTERIAL VAGINOSIS
 ELK GROVE VILLAGE, Ill., Aug. 27 /PRNewswire/ -- Curatek Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved MetroGel-Vaginal (metronidazole vaginal gel, 0.75 percent) as safe and effective for the treatment of bacterial vaginosis, widely considered the most common vaginal infection in the United States and increasingly linked to serious medical complications.
 "MetroGel-Vaginal represents an important advance in the protection of women's health," said Dr. Robert Borgman, president of Curatek. "It offers significant improvement over existing therapy for this widespread condition because of its demonstrated high efficacy and superior safety profile."
 The company plans to distribute the new prescription drug to wholesale druggists and retail pharmacies over the coming weeks.
 Perhaps the most embarrassing type of vaginal infection, bacterial vaginosis is characterized by a foul or "fishy" vaginal odor in varying degrees, a high (alkaline) vaginal pH level, an excessive white or grey vaginal discharge of milk-like consistency that can stain undergarments, and the presence of "clue" cells -- epithelial cells coated with bacteria that can be seen under microscopic examination of vaginal secretions.
 Epidemiological studies have identified bacterial vaginosis in 10 to 25 percent of women in normal clinic populations, and the condition has been linked to increased risk of pelvic inflammatory disease, inflamation of the fallopian tubes, postoperative infection, preterm labor and delivery, post-partum endometritis and other complications.
 MetroGel-Vaginal is the first intravaginal formulation of metronidazole, which in traditional oral form has become the standard therapy for bacterial vaginosis because of its potent and unique targeted action against the anaerobic bacteria that cause the condition. The intravaginal product achieves comparable effectiveness against bacterial vaginosis while producing peak systemic blood levels of only 2 percent of the oral drug, resulting in greater safety potential and only minimal side effects in clinical studies. Oral metronidazole is known to produce a high level of gastrointestinal side effects such as nausea and vomiting.
 Moreover, unlike broad spectrum antibiotics such as ampicillin and clindamycin, MetroGel-Vaginal does not destroy the lactobacilli that protect against the overgrowth of yeast and other pathogenic bacteria. In addition, MetroGel-Vaginal is formulated at a pH level of 4.0, which is the normal vaginal pH level, whereas the pH of women with bacterial vaginosis is usually above 4.5.
 MetroGel-Vaginal has been found convenient and easy to use, and has received excellent patient acceptance. The product is formulated in an innovative water-based gel that is greaseless, colorless, odor free and non-staining. It is supplied in a 70-gram tube along with a vaginal applicator, and the recommended dosage regimen is five days of therapy, morning and evening.
 In multi-center, controlled clinical studies involving more than 300 women, MetroGel-Vaginal demonstrated high efficacy, minimal side effects, enhancement of normal protective lactobacilli and a low incidence of yeast overgrowth. Yeast overgrowth is associated with the use of many broad spectrum antibiotics.
 The clinical studies were conducted by researchers at the University of Washington, University of Colorado, Duke University and several other universities.
 Curatek Pharmaceuticals specializes in the development and marketing of prescription products for dermatology, gynecology and other therapeutic areas. Its headquarters are located in Elk Grove Village, Ill.
 -0- 9/27/92
 /CONTACT: John Presutti, 708-806-7680, or Sam Huff, 708-382-7404, both for Curatek/ CO: Curatek Pharmaceuticals ST: Illinois IN: MTC SU: PDT


GK -- NY044 -- 3926 08/27/92 11:54 EDT
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Date:Aug 27, 1992
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