SAN ANTONIO, TX (August 17, 2006) – Mission Pharmacal today announced that the company has submitted a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for a new indication for Tindamax® (tinidazole) as treatment of bacterial vaginosis (BV), the most common vaginal infection in the United States. If the sNDA is approved by the FDA, Tindamax® would provide a shorter course oral treatment option than the current standard of care used to treat bacterial vaginosis.
The sNDA for Mission Pharmacal is supported by data from a randomized, placebo-controlled, double blind multi-center trial evaluating two dosing regimens of Tindamax® (tinidazole). In the study, patients with BV were randomized to one of three treatment arms: 2g of Tindamax® once daily for two days, 1g of Tindamax® once daily for five days, or placebo.
Underlining the need for broader education about trich, the Centers for Disease Control and Prevention (CDC) today released findings from the first report on the prevalence of trich in a nationally representative sample of American women. The report found that 3.1 percent of respondents were infected with trichomoniasis. An estimated 7.4 million new cases of trich are reported annually in the United States today, compared with 3 million new cases of chlamydia and 700,000 cases of gonorrhea, according to the CDC's STD Web site.
About Bacterial Vaginosis
As the most widespread form of vaginal infection, BV is one of the main causes of the 10 million doctor visits for vaginitis in the United States 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.
BV is associated with an increased risk for contracting a sexually transmitted disease, including HIV. Additionally, women who suffer from BV are at increased risk for pelvic inflammatory disease, endometritis, post-operative infections following gynecologic surgery, and other obstetrical and gynecological complications.
Sexual partners should be treated simultaneously for maximum efficacy and prevention of re-infection. More information on trich is available at www.trichomoniasis.org.
About Tindamax®
Tindamax® is a second-generation 5-nitroimidazole, chemically related to metronidazole, a first-generation nitroimidazole compound. Tindamax® has been found in studies of trichomoniasis patients to provide an improved side-effect profile with a low incidence of nausea and vomiting, and a long duration of action, with therapeutic concentrations remaining for 48 hours following a single 2g dose. In addition, tinidazole spares protective vaginal lactobacilli. Tinidazole is indicated for BV treatment in many European countries About Mission Pharmacal
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.
Contraindications
- Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives
- First trimester of pregnancy
- Nursing mothers, unless breast-feeding is interrupted during tinidazole therapy and for 3 days following the last dose
Warnings and Precautions
- Seizures and neuropathy have been reported. Discontinue Tindamax if abnormal neurologic signs develop
- Vaginal candidiasis may develop with Tindamax and require treatment with an antifungal agent
- Use Tindamax with caution in patients with blood dyscrasias. Tindamax may produce transient leukopenia and neutropenia
Adverse Reactions
Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.
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