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FDA Approves Tindamax(R) For Bacterial Vaginosis
Mission Pharmacal today announced
that the U.S. Food and Drug Administration (FDA) approved Tindamax(R)
(tinidazole) for the treatment of bacterial vaginosis (BV), the most common
vaginal infection among women of childbearing age in the United States.
Tindamaxis the first new oral therapy to be approved for the treatment of
BV in a decade, and provides a shorter course oral treatment, with fewer
doses per day and a better tolerability profile, than the current standard
of care. Tindamaxis the only FDA approved treatment for both BV and
trichomoniasis, two conditions which are highly prevalent and often
overlap. Trichomoniasis is the most common curable sexually transmitted
disease in the United States.
As the most widespread form of vaginal infection, BV affects almost
one- third of women in the United States (29.2 percent) and is one of the
main causes of the 10 million doctor visits for vaginitis in the country
annually. BV is caused when the normal balance of bacteria in the vagina is
disturbed and replaced by an overgrowth of certain bacteria. Many women
with BV do not experience any symptoms; when they do, symptoms include
abnormal vaginal discharge with an unpleasant odor, burning during
urination, or itching in the genital area.
Tindamaxis administered as one gram (two tablets) once daily for five
days or two grams (four tablets) once daily for two days, compared to the
twice- daily, seven day oral dosing of metronidazole, the current standard
of care.
"We are extremely pleased to be able to provide women with the first
new oral treatment for BV in a decade," said Neil Walsdorf, Jr., President
of Mission Pharmacal. "Because Tindamax provides a shorter course of
therapy with a better tolerability profile, we are confident it will set a
new standard of care in oral therapy for the treatment of BV."
Unlike intravaginal treatments, Tindamax treats the entire reproductive
tract, including the upper tract, where BV has been shown to migrate.
According to the Centers for Disease Control and Prevention (CDC), if left
untreated, BV can increase a woman's susceptibility to sexually transmitted
diseases such as chlamydia, gonorrhea, and HIV, if she is exposed to these
diseases. The untreated bacteria also may infect other female organs and
cause serious complications such as pelvic inflammatory disease and
cervicitis. In pregnant women, BV is associated with an increased risk of
early pregnancy loss, premature delivery, and delivery of a
low-birth-weight baby.
The FDA approval of Tindamax for BV is supported by data from a
randomized, placebo-controlled, double-blind multi-center trial evaluating
two dosing regimens of Tindamax. In the study, 235 women with BV were
randomized to one of three treatment arms: two grams of Tindamax once daily
(four tablets) for two days, one gram of Tindamax (two tablets) once daily
for five days, or placebo. Both Tindamax regimens exhibited superior
efficacy than placebo, with a cure rate of 27.4 percent in the two grams
once daily for two days group and 36.8 percent in the one gram once daily
for five days group, compared to a cure rate of 5.1 percent in the placebo
group. Cure rate was defined using the FDA Guidance Criteria, the most
rigorous criteria available.
"Compared with other oral treatments for BV currently recommended,
Tindamax therapy reduces the total number of treatment doses by more than
half. Shorter courses of therapy have been shown to improve patient
compliance, which is important when treating a condition like BV," said
Jeanne Marrazzo, M.D., MPH, Associate Professor of Medicine, Department of
Infectious Diseases, University of Washington in Seattle.
In the pivotal trials, adverse events in patients treated with Tindamax
were minimal and comparable across both treatment groups and the placebo
group, and included metallic taste and nausea. Tindamax is associated with
a low incidence of gastrointestinal side effects.
About Tindamax
Tindamax, a second-generation 5-nitroimidazole compound, is indicated
in the United States for the treatment of bacterial vaginosis,
trichomoniasis, the intestinal infections giardiasis and intestinal
amebiasis, and amebic liver abscess. It has been approved for use in the
United States since May 2004 and is recognized as one of the drugs of
choice for the treatment of trichomoniasis by the CDC.
Tindamax has been found to have a favorable side effect profile with a
low incidence of nausea and vomiting. In clinical trials of patients
treated with a single two gram dose of tinidazole for trichomoniasis and
giardiasis, adverse effects experienced by more than one percent of
patients included metallic or bitter taste, nausea, anorexia, abdominal
discomfort, vomiting, constipation, diarrhea, general weakness or fatigue,
dizziness, and headache.
Carcinogenicity has been seen in mice and rats treated chronically with
metronidazole, another nitroimidazole agent. Although such data have not
been reported for tinidazole, the two drugs are structurally related and
have similar biologic effects. Use should be limited to approved
indications only.
The use of tinidazole in pregnant patients has not been studied.
Tindamax should not be administered to women in their first trimester of
pregnancy.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Tindamax and other antibacterial drugs, Tindamax should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
About Bacterial Vaginosis
As the most widespread form of vaginal infection, affecting nearly one-
third of women in the United States, BV is one of the main causes of the 10
million doctor visits for vaginitis in the country annually. Approximately
4.5 million prescriptions are written for BV treatment each year in the
United States.
BV symptoms include a foul or fishy odor in varying degrees and a milk-
like vaginal discharge. Signs of BV also include a vaginal pH level
exceeding 4.5 and the presence of clue cells seen in a microscopic
evaluation of vaginal discharge. Clue cells are vaginal epithelial cells
coated with bacteria. BV is caused by an overgrowth of anaerobic bacteria
in the vagina, with a concomitant decrease in protective lactobacilli.
About Mission Pharmacal
Mission Pharmacal, the maker of Citracal(R), is a family-owned
pharmaceutical company based in San Antonio. For more than 60 years, the
company has been dedicated to identifying unmet health needs in the
marketplace and developing innovative prescription and over-the-counter
products to meet them. Currently, Mission Pharmacal provides physicians and
consumers with pharmaceutical, nutritional and diagnostic products. For
more information, visit http://www.missionpharmacal.com.
Mission Pharmacal
http://www.missionpharmacal.com
View drug information on Tindamax, tinidazole.
FDA a aprobat Tindamax (R) pentru bacteriene Vaginosis - FDA Approves Tindamax(R) For Bacterial Vaginosis - articole medicale engleza - startsanatate