FDA OKs New Bacterial Vaginosis Drug

May 24, 2007 -- The FDA has approved the antibacterial drug Tindamax to treat bacterial vaginosis, the most common vaginal infection in women of childbearing age.

Bacterial vaginosis is linked to an imbalance in vaginal bacteria, with an overgrowth of "bad" bacteria vs. "good" bacteria, notes the CDC.

Tindamax is the first new oral treatment for bacterial vaginosis in a decade, according to a news release issued today by Mission Pharmacal, which makes Tindamax.

The FDA first approved Tindamax in 2004 for treating three other infections:

• Trichomoniasis, a sexually transmitted disease (STD)
• Giardiasis, an intestinal infection
• Amebiasis, an intestinal infection that may also affect the liver

According to Mission Pharmacal, the FDA approved Tindamax for the treatment of bacterial vaginosis based on a clinical trial of 235 women with bacterial vaginosis.

The researchers split the women into three groups. One group took four Tindamax tablets daily for two days. Another group took two Tindamax pills daily for five days. The third group took an inactive pill (placebo).

Both Tindamax doses were superior to the placebo, with cure rates of 27% for the two-day Tindamax treatment, 37% for the five-day Tindamax treatment, and 5% for the placebo.

The FDA approved both Tindamax doses for bacterial vaginosis treatment.

Mission Pharmacal notes "minimal" side effects in Tindamax trials, including metallic taste and nausea.