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 U.S.
In the study, patients with BV were randomized to one of three treatment arms: 2 g of Tindamax once daily for two days, 1 g of Tindamax once daily for five days, or placebo.
Based on results from the trial, the company plans to file a supplemental new drug application (sNDA) for the use of Tindamax as a treatment for BV with the FDAin the second quarter of 2006. Tindamax is currently approved in the U.S. for the treatment of trichomoniasis, the intestinal infections giardiasis and intestinal amebiasis, and amebic liver abscess.