Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active...
Reexamination Certificate
2000-12-21
2002-11-12
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
C424S078170, C424S451000, C424S464000, C424S422000, C424S430000, C424S436000, C424S434000, C424S400000
Reexamination Certificate
active
06479045
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to compositions and methods for preventing miscarriage and premature labor, and for treating and preventing Bacterial Vaginosis.
BACKGROUND OF THE INVENTION
Bacterial Vaginosis (BV) is broadly defined as a shift in vaginal ecology from a normal lactobacillus dominated flora to a profuse mixed microbial flora consisting of facultative and anaerobic organisms. An ancient condition first described by Hippocrates, BV is now the most common vaginal disorder in women of reproductive age, Kent, H. L.,
Epidemiology of vaginitis, A. J Obstet. Gynecol
. 1991 165:1168, afflicting 15 to 20 percent of all women at any given time. In the United States, BV is the leading variety of vaginal infection, affecting a broader spectrum of women than gonorrhea. Id.
A primary medical significance of BV is its impact upon the quality of fetal implantation and its potential to induce premature labor, resulting in low birth-weight infants. BV during pregnancy also has been associated with an increased risk of late miscarriage. Kurki, T, et al.,
Bacterial vaginosis in early pregnancy and pregnancy outcome, Obstet. Gynecol
. 1992, 80:173-77; Riduan, J. M. et al.,
Bacterial vaginosis and prematurity in Indonesia: Association in early and late pregnancy, Am. J. Obstet. Gynecol
. 1993, 169:175-78; Hay, P. E., et al.,
Abnormal bacterial colonization of the genital tract and subsequent preterm delivery and late miscarriage, BMJ
1994, 308:295-98; McGregor, J. A., et al.,
Prevention of premature birth by screening and treatment for common genital tract infections results of a prospective controlled evaluation, Am J. Obstet. Gynecol.
1995, 173:157-67, Hillier, S. L., et al.,
Association between bacterial vaginosis and preterm delivery of a low birth-weight infant, N. Engl. J. Med
. 1995, 333,1737-42; Watts, D. H., et al.,
Bacterial vaginosis as a risk factorforpost
-
cesarean endometriosis, Obstet. Gynecol
. 1990, 75,52-58.
The prevalence of BV in pregnant women is reported to be about 13 to 31 percent. Kurki, T, et al.,
Bacterial vaginosis in early pregnancy and pregnancy outcome, Obstet. Gynecol
. 1992, 80,173-77. Riduan, J. M. et al.,
Bacterial vaginosis and prematurity in Indonesia: Association in early and late pregnancy, Am. J. Obstet. Gynecol
. 1993, 169:175-78; Hay, P. E., et al.,
Abnormal bacterial colonization of the genital tract and subsequent preterm delivery and late miscarriage, BMJ
1994, 308:295-98; McGregor, J. A., et al.,
Prevention of premature birth by screening and treatment for common genital tract infections: results of a prospective controlled evaluation, Am J. Obstet. Gynecol
. 1995, 173:157-67; Hillier, S. L., et al.,
Association between bacterial vaginosis and preterm delivery of a low birth
-
weight infant, N. Engl. J. Med
. 1995, 333:1737-42. In women undergoing in-vitro fertilization, BV is associated with increased risk of miscarriage in the first trimester. Ralph, S. G. et al.,
Influence of bacterial vaginosis on conception and miscarriage in the first trimester. Cohort study, BMJ
1999, 319,220-3. Even if the fetus of a woman suffering from BV does survive the first and second trimester, however, the mother still faces an increased risk of premature labor with a higher probability of a low birthweight infant and the attendant problems and consequences.
The exact pathogenesis and medical classification (e.g., disease or condition) of BV is uncertain. Under normal conditions, lactobacillus bacteria are predominant in the vagina and are believed to regulate the growth of other vaginal flora by producing hydrogen peroxide (H
2
O
2
). In women with BV, however, normal vaginal lactobacilli are replaced by an overgrowth of Gardnerella vaginalis, anaerobes, and mycoplasmas, with a concomitant decrease in lactobacilli. Thus, while H
2
O
2
-producing lactobacilli can be found in women with BV, these may not be enough to overcome the onslaught of multiplying endogenous bacteria that in turn force out lactobacilli as the dominant member of the flora. Rosenstein, I. J., et al,
Relationship between hydrogen peroxide producing strains of lactobacilli and vaginosis associated with bacterial species in pregnant women, Eur. J. Clin. Microbial. Infect. Dis
. 1997, 6:517-22.
The diagnostic signs of BV include increased vaginal discharge, production of “fishy” smelling amines, vaginal pH above 4.7, and presence of clue cells within a mixed flora. These were first described by Gardner and Dukes in 1955, Gardner H. L., Dukes, D. C.,
Haemophilus vaginalis vaginitis. A newly defined specific infection previously classified “nonspecific vaginitis, Am. J. Obstet. Gynecol
. 1955, 69:962-76, and defined as the basic diagnostic criteria for BV in 1983. Amsel, R., et al.,
Nonspecific Vaginitis. Diagnostic criteria and microbial and epidemiologic associations, Am. J. Med.
1983, 74:14-22.
A woman may or may not experience the symptoms of BV; many women, however, complain of foul, fishy odor and excessive vaginal discharge that stains undergarments. The odor is particularly prominent for 24 hours after unprotected intercourse because of the high pH (7.8-8.2) and extensive buffering capacity of semen. Women who have recently acquired BV may be more aware of abnormal odor and discharge than a woman who has had the problem for months or even years. Often women first recognize that they had a problem after appropriate therapy. Further, many healthy women consider the symptoms of BV to indicate a lack of proper hygiene, rather than a medical problem.
In the United States, the unpleasant odor and discharge associated with BV causes many women to seek diagnosis and cure, which can be both inconvenient and costly. While millions seek the help of a physician for such problems, an even larger number (approximately 30% of all adult American women) often use douches purchased without a prescription, rather than seek medical advice.
The idea of washing out the foul smelling discharge with an acidic douche may have a simplistic appeal. Medically, however, douching is frowned upon as studies have demonstrated an association between douching and Pelvic Inflammatory Disease (PID), ectopic pregnancy, tubal infertility, and reduced fertility. Aral, S. O., et at., Self-reported pelvic inflammatory disease in the United States, 1988
, JAMA
1991, 266:2570-3; Wolner-Hansen, P., et al.,
Association between vaginal douching and acute pelvic inflammatory disease, JAMA
1990, 263:1936-41; Scholes, D., et al.,
Vaginal douching as a risk factor for acute pelvic inflammatory disease, Obstet. Gynecol
. 1993, 81:601-6; Chow, W-H, et al.,
Vaginal douching as a riskfactor for tubal ectopic pregnancy, Am. J. Obstet
. 1985, 153:727-9; Chow, J. M., et al.,
The association between Chlamydia trachomatis and ectopic pregnancy, JAMA
1990, 263:3164-7; Darling J. R., et al.,
Vaginal douching and the risk of tubal pregnancy, Epidemiology
1991, 2:40-8; Kendrick, J. S., et al.,
Vaginal douching and the risk of ectopic pregnancy among black women, Am. J. Obstet. Gynecol
. 1997, 176:991-7; Baird, D. D., et al.,
Vaginal Douching and reduced fertility, Am. J Public Health
1996, 86:844-50.
Traditional treatments of BV have focused on long-term cure. Treatment with the classic agents metronidazole and clindamycin have resulted in an approximately 70 percent cure rate within one month. Amsel, R., et al.,
Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations, Am. J. Med
1983, 74:14-22; Larsson, P. G.,
Treatment for bacterial vaginosis: an update on the expected cure rate, Int'l J. of STD & AIDS
1997, 8:35-6. Nevertheless, only half of the women treated successfully will have a long-term cure. Larsson, P. G., et al.,
Treatment of bacterial vaginosis in women with vaginal bleeding complications or discharge or harboring Mobiluncus, Obstet. Gynecol
. 1990, 29:296-300. Most relapses occur in the first year, often correlating to the introduction of a new sexual partner. Id. Thus, control of chronic BV is of primary importance to those who must deal wit
Bologna William J.
Levine Howard L.
Columbia Laboratories, Inc.
Di Nola-Baron Liliana
Page Thurman K.
Winston & Strawn
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