SAN ANTONIO, TX (July 31, 2007) – A study published in the August 1st issue of Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists (ACOG), finds that Mission Pharmacal's Tindamax® (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 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 clinical criteria used to establish BV diagnosis at study entry, this study used rigorous FDA-recommended criteria to define cure as resolution of five diagnostic criteria. 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, MD, 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 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. For more information, visit www.missionpharmacal.com.
Media Contact:
Ami Shah
cohn&wolfe
(212) 537-8048
ami.shah@cohnwolfe.com
Important Safety Information
WARNING: POTENTIAL RISK FOR CARCINOGENICITY
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. Its use should be reserved for the conditions described in INDICATIONS AND USAGE.
Tindamax® is a prescription antibiotic used to treat certain infections caused by bacteria and parasites. It is approved for treating trichomoniasis, also known as "trich," and bacterial vaginosis, or "BV" (in non-pregnant, adult women). It is also approved for treating giardiasis, also known as "giardia," amebiasis, and amebic liver abscess in patients age 3 and older.
Important Safety Information
Tindamax® is not for everyone. You should not take Tindamax® if you are in the first trimester of pregnancy. If you are nursing, Tindamax® can pass through your breast milk, so you should not take it unless you stop breastfeeding during your prescription and for 3 days after your last dose.
Tindamax® can lead to a temporary reduction in your white blood cells, so if you have been diagnosed with a blood disorder, talk to your doctor before starting a prescription.
Do not take Tindamax® if you have a history of sensitivity to tinidazole or related drugs in the nitroimidazole family. Reactions can range from mild itching, hives, or fever to Stevens-Johnson syndrome, which is a rare, life-threatening skin condition.
Certain drugs may interact with Tindamax®, so always tell your doctor about the medications you're taking before you start a prescription.
Take each dose of Tindamax® with food to lessen the risk of stomach upset and other GI side effects. Avoid any alcoholic beverages while taking Tindamax® and for 3 days afterward.
If you are undergoing hemodialysis while taking Tindamax® on the same day, consult your doctor for the appropriate dose of Tindamax®. An additional half-dose of Tindamax® at the end of dialysis may be recommended.
Antibacterial drugs, including Tindamax®, do not treat viral infections such as the common cold. When taking Tindamax® to treat a bacterial infection, it is very common to feel better early in your prescription; however, you should keep taking the medication as directed and for as long as directed by your doctor. Skipping doses or not taking all of your medication can make Tindamax® less effective. It can also allow the bacteria to build up resistance to the drug, so that it won't be treatable with Tindamax® or similar drugs in the future.
The most common side effects of Tindamax® are a metallic or bitter taste, nausea, weakness, fatigue, discomfort, indigestion, cramps, vomiting, loss of appetite, headache, dizziness, and constipation.
Some patients taking Tindamax® may also develop a yeast infection, which can require treatment with an anti-fungal drug. Talk to your doctor if you notice any unusual symptoms.
Certain patients taking Tindamax® have experienced seizures or nerve problems, with symptoms such as numbness or tingling of the hands or feet. Other side effects included vertigo, unsteady movements, insomnia, or drowsiness. Stop taking Tindamax® if you develop any abnormal symptoms.
Tinidazole, the key ingredient in Tindamax®, is related to a drug called metronidazole, which has been linked to cancer in lab rats and mice that received the drug over long periods of time. Although these effects have not been reported for tinidazole, the two drugs are chemically related and have similar effects on the body. Therefore, Tindamax® should only be used to treat infections it has been approved to treat.
To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
