A study published in the August
issue of Obstetrics & Gynecology, the official publication of the American
College of Obstetricians and Gynecologists (ACOG), finds that Mission
Pharmacal’s Tindamax(R) (tinidazole) is an effective and well-tolerated
treatment for bacterial vaginosis (BV), the most common vaginal infection
among women of childbearing age in the United States. BV affects almost
one-third of women in the United States and is one of the main causes of
the 10 million doctor visits for vaginitis in the country annually.
The randomized, double-blinded study found that a 1 gram once daily,
five- day course of treatment with Tindamax resulted in a therapeutic cure
rate of 36.8 percent, significantly greater than the rate of 5.1 percent
seen with placebo (P<.0001). Tindamax also was shown to have a safety and
tolerability profile comparable to placebo.
While previous studies evaluating BV therapies have defined cure as
resolution of only three or four of Amsel’s criteria used to establish BV
diagnosis at study entry, this study used rigorous FDA-recommended criteria
to define therapeutic cure as resolution of all 4 of Amsel’s criteria plus
a microbiological cure with the return of the vaginal flora to normal
(Nugent’s score, defined as < 4). More traditional definitions of cure
based only on clinical criteria produced substantially higher cure rates
for the five-day regimen of Tindamax in this study.
“The results of this study clearly demonstrate Tindamax’s ability to
effectively treat BV in a shorter course of therapy without the side
effects typically associated with older therapies,” said Charles H.
Livengood III, M.D., the primary investigator of the study and an associate
professor of obstetrics and gynecology at Duke University, Durham, North
Carolina. “Both of these advantages are likely to lead to patients
finishing the full course of treatment, which is important when treating a
bacterial condition like BV.”
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. 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,
according to the Centers for Disease Control and Prevention (CDC).
Approved earlier this year as the first new oral therapy for the
treatment of BV in a decade, Tindamax provides a shorter course oral
treatment, with fewer doses per day and a better tolerability profile, than
the current standard of care. Unlike intravaginal treatments, Tindamax
treats the entire reproductive tract, including the upper tract, where BV
has been shown to migrate.
“The publication of these data in the ACOG journal marks another
important milestone for Tindamax, which was approved by the FDA to treat
bacterial vaginosis in May of 2007,” said Neil Walsdorf, Jr., president of
Mission Pharmacal. “With its shorter course of therapy and better
tolerability profile, we are confident that Tindamax will be the new
standard of care in oral therapy for the treatment of BV.”
Tindamax is 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.
About the Study
A total of 235 women, enrolled at 10 geographically diverse centers in
the United States, participated in the study. Two different regimens of
Tindamax were compared to placebo to evaluate efficacy, safety, and
tolerability in the treatment of BV at 21 to 30 days after treatment. A
regimen of Tindamax 2 grams once daily for two days demonstrated a cure
rate of 27.4 percent (p < 0.0002), using the rigorous FDA-recommended
criteria. Nausea was significantly more frequent among patients receiving
this regimen of Tindamax than those receiving placebo.
Overall, Tindamax was well-tolerated the study, as evidenced by the
high compliance with therapy in both Tindamax treatment arms. No patient
withdrew from either Tindamax arm of the study, and compliance with study
therapy, tolerability, and safety were comparable in the three arms of the
study. Dysgeusia (metallic taste) was the only adverse event reported
significantly more frequently among patients receiving the five-day
Tindamax regimen. All gastrointestinal symptoms were comparable in the
Tindamax and placebo groups.
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 Centers for Disease
Control and Prevention (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 2 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, Texas. 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