First New Oral Treatment for Bacterial Vaginosis in a Decade
SAN ANTONIO, TX (May 24, 2007) – Mission Pharmacal today announced that the U.S. Food and Drug Administration (FDA) approved Tindamax® (tinidazole) for the treatment of bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age in the United States. Tindamax® is 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. 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.
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.
Tindamax® is 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, 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 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.
