FDA News

FDA Approves First New Oral Treatment for Bacterial Vaginosis

(May 25, 2007)-- Mission Pharmacal announced that the U.S. Food and Drug Administration (FDA) approved Tindamax (tinidazole) for the treatment of bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age in the United States. Tindamaxis the first new oral therapy to be approved for the treatment of BV in a decade, and provides a shorter course oral treatment, with fewer doses per day and a better tolerability profile, than the current standard of care. Tindamaxis the only FDA approved treatment for both BV and trichomoniasis, two conditions which are highly prevalent and often overlap. Trichomoniasis is the most common curable sexually transmitted disease in the United States.

As the most widespread form of vaginal infection, BV affects almost one- third of women in the United States (29.2 percent) and is one of the main causes of the 10 million doctor visits for vaginitis in the country annually. BV is caused when the normal balance of bacteria in the vagina is disturbed and replaced by an overgrowth of certain bacteria. Many women with BV do not experience any symptoms; when they do, symptoms include abnormal vaginal discharge with an unpleasant odor, burning during urination, or itching in the genital area.

Tindamaxis administered as one gram (two tablets) once daily for five days or two grams (four tablets) once daily for two days, compared to the twice- daily, seven day oral dosing of metronidazole, the current standard of care.

Unlike intravaginal treatments, Tindamax treats the entire reproductive tract, including the upper tract, where BV has been shown to migrate. According to the Centers for Disease Control and Prevention (CDC), if left untreated, BV can increase a woman's susceptibility to sexually transmitted diseases such as chlamydia, gonorrhea, and HIV, if she is exposed to these diseases. The untreated bacteria also may infect other female organs and cause serious complications such as pelvic inflammatory disease and cervicitis. In pregnant women, BV is associated with an increased risk of early pregnancy loss, premature delivery, and delivery of a low-birth-weight baby.

The FDA approval of Tindamax for BV is supported by data from a randomized, placebo-controlled, double-blind multi-center trial evaluating two dosing regimens of Tindamax. In the study, 235 women with BV were randomized to one of three treatment arms: two grams of Tindamax once daily (four tablets) for two days, one gram of Tindamax (two tablets) once daily for five days, or placebo. Both Tindamax regimens exhibited superior efficacy than placebo, with a cure rate of 27.4 percent in the two grams once daily for two days group and 36.8 percent in the one gram once daily for five days group, compared to a cure rate of 5.1 percent in the placebo group. Cure rate was defined using the FDA Guidance Criteria, the most rigorous criteria available.

In the pivotal trials, adverse events in patients treated with Tindamax were minimal and comparable across both treatment groups and the placebo group, and included metallic taste and nausea. Tindamax is associated with a low incidence of gastrointestinal side effects.

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