Mission Pharmacal's Tindamax gets FDA OK

USA-based family-owned pharmaceutical company Mission Pharmacal says that the Food and Drug Administration has approved its anti-infective Tindamax (tinidazole) as a treatment for bacterial vaginosis. The agent, which is a second-generation 5-nitroimidazole, is also cleared for the treatment of the related sexually-transmitted disease trichomoniasis.

The FDA's approval of Tindamax for BV is based on the results of a randomized, placebo-controlled, double-blind, multicenter trial that examined two dosing regimens in 235 women suffering from the infection. Subjects were provided with one or two grams of the compound, or placebo, for periods of two or five days, respectively.

The results showed that both regimens were superior to control, with cure rates of 27.4% and 36.8% recorded for the two dosage groups. In addition, adverse events caused by the drug were described as being minimal and comparable with those in the placebo cohort.