SAN ANTONIO, May 8 /PRNewswire/ -- Mission Pharmacal today announced the successful completion of a randomized, placebo-controlled, double blind multi-center trial evaluating two dosing regimens of Tindamax(R) (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(R) as a treatment for BV with the U.S. Food and Drug Administration (FDA) in the second quarter of 2006. Tindamax(R) 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(R) once daily for two days, 1g of Tindamax(R) once daily for five days, or placebo.
“Tindamax(R) 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(R)
Tindamax(R) is a second-generation 5-nitroimidazole, chemically related to metronidazole, a first-generation nitroimidazole compound. Tindamax(R) 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, the maker of Citracal(R), is a family-owned pharmaceutical company based in San Antonio. For more than 50 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 http://www.missionpharmacal.com .
Mission Pharmacal
CONTACT: Magali St. John Sutton of GCI Group for Mission Pharmacal,+1-212-537-8104, mstjohnsutton@gcigroup.com
Web site: http://www.missionpharmacal.com/
