FDA OKs New Bacterial Vaginosis Drug
Tindamax Already in Use for Treatment of Trichomoniasis
May 24, 2007 -- The FDA has approved the antibacterial drug Tindamax to
treat bacterial vaginosis, the most common vaginal infection in women of
Bacterial vaginosis is linked to an imbalance in vaginal bacteria, with an
overgrowth of "bad" bacteria vs. "good" bacteria, notes the
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
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
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
Mission Pharmacal notes "minimal" side effects in Tindamax trials,
including metallic taste and nausea.