SAN ANTONIO, Texas, Aug. 17 /PRNewswire/ -- 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(R) (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(R) would provide a shorter course oral treatment option than the current standard of care used to treat bacterial vaginosis.
The sNDA for Mission Pharmacal(R) is supported by data from a randomized, placebo-controlled, double blind multi-center trial evaluating two dosing regimens of Tindamax(R) (tinidazole). 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) is currently approved in the United States for the treatment of trichomoniasis, the intestinal infections giardiasis and intestinal amebiasis, and amebic liver abscess.
“We are pleased to be submitting Tindamax(R) data to the FDA and will work closely with the Agency throughout the review process,” said Neil Walsdorf, Jr., President of Mission Pharmacal. “If approved for this newest indication, Tindamax(R) would provide a new treatment option for a condition that results in 10 million office visits each year. We believe that the shorter course oral treatment of Tindamax(R) may offer added convenience for women in managing BV.”
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: Lauren Graham of GCI Group for Mission Pharmacal,+1-212-537-8129, or lgraham@gcigroup.com
Web site: http://www.missionpharmacal.com//
