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news.Mission Pharmacal has successfully completed a randomized multi-center trial evaluating two dosing regimens of Tindamax for the treatment of bacterial vaginosis, the most common vaginal infection in the US.
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Based on results from the trial, Mission Pharmacal plans to file a supplemental new drug application (sNDA) with the FDA for the use of Tindamax (tinidazole) as a treatment for bacterial vaginosis (BV) in the second quarter of 2006.
Tindamax is currently approved in the US for the treatment of trichomoniasis, the intestinal infections giardiasis and intestinal amebiasis, and amebic liver abscess. It is also already indicated for BV treatment in many European countries.
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 at Wayne State University in Detroit, and one of the lead investigators of the phase III study.
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 US annually. Approximately 4.5 million prescriptions are written for BV treatment each year in the US.
BV is also 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.