SAN ANTONIO, TX (May 8, 2006) – Mission Pharmacal today announced the successful completion of a randomized, placebo-controlled, double blind multi-center trial evaluating two dosing regimens of Tindamax® (tinidazole) for the treatment of bacterial vaginosis (BV), the most common vaginal infection in the United States.
Based on results from the trial, Mission Pharmacal plans to file a supplemental New Drug Application (sNDA) for the use of Tindamax® as a treatment for BV with the U.S. Food and Drug Administration (FDA) in the second quarter of 2006. Tindamax® is currently approved in the United States for the treatment of trichomoniasis, the intestinal infections giardiasis and intestinal amebiasis, and amebic liver abscess.
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.
"Tindamax® may offer a significant advance in the control of bacterial vaginosis, as a shorter course oral treatment option than the current standard of care," said Dr. Jack Sobel, Professor of Medicine and Infectious Diseases, Wayne State University in Detroit, and one of the lead investigators of the Phase III study.
Other centers and investigators for the clinical trials included: Dr. David Soper, Medical University of South Carolina, Charleston; Dr. Harold Wiesenfeld, Magee-Womens Hospital, Pittsburgh; Dr. Charles Livengood, Duke University, Durham, North Carolina; Dr. Daron Ferris, Medical College of Georgia, Augusta; Dr. Paul Nyirjesy, Drexel University, Philadelphia; Dr. Stephanie Taylor, Louisiana State University, New Orleans; Dr. Jeanne Marrazzo, University of Washington, Seattle; Dr. Ashwin Chatwani, Temple University, Philadelphia; and Dr. Paul Fine, Planned Parenthood, Houston. Microbiologic evaluations were performed in the laboratory of Dr. Sharon Hillier, at Magee-Womens Hospital in Pittsburgh.
"Mission Pharmacal is committed to providing treatments that address common health concerns, especially among women," said Neill Walsdorf, Jr., President of Mission Pharmacal. "The completion of this study is an important milestone for the company and gives Mission Pharmacal a larger role in the vaginitis treatment market."
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.
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
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.
