Mission Pharmacal completes Ph III Tindamax trial

USA-based drugmaker Mission Pharmacal says that it has completed a Phase III study of its drug Tindamax (tinidazole), used in the treatment of bacterial vaginosis. BV is the most commonly occurring infection of its type in the USA, and is thought to be responsible for around 10 million doctor visits each year.

The study, which was a randomized, placebo-controlled, double-blind, multicenter assessment, evaluated the drug in two dosing regimens for efficacy in the treatment of the condition. Enrolled subjects were randomized to receive 1g or 2g of the drug per day or placebo for a period of five days.

Commenting on the results, lead study investigator Jack Sobel, professor of medicine and infectious diseases, Wayne State University in Detroit, said: "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." The firm went on to say that data from the trial would be used as the basis for the filing of a supplemental New Drug Application with the Food and Drug Administration in the second quarter of the year.