FDA Approves New Drug for Bacterial Vaginosis
Tindamax, the first new oral treatment for bacterial vaginosis in a decade, has been approved by the U.S. Food and Drug Administration, Mission Pharmacal of San Antonio, Texas announced Tuesday.
The new drug provides a shorter course of treatment, with fewer doses per day, than metronidazole, the current standard of care, the company said. Patients take two tablets (a total of one gram) of Tindamax once a day for five days or four tablets (two grams) once daily for two days. Metronidazole is taken twice-daily for seven days.
The FDA approval is supported by a study of 235 women with bacterial vaginosis that reported a cure rate of 27.4 percent for women who took two grams daily for two days and a cure rate of 36.8 percent for women who took one gram daily for five days. Women who took a placebo had a cure rate of 5.1 percent.
Side effects included nausea, anorexia, abdominal discomfort, vomiting, constipation, diarrhea, weakness/fatigue, dizziness and headache.
Bacterial vaginosis, which affects about a third of women in the United States, is the most common vaginal infection among women of childbearing age. The infection often causes no symptoms. Left untreated, it can increase a woman's susceptibility to other sexually transmitted diseases and the risk of pelvic inflammatory disease and cervicitis.
Tindamax is also approved to treat trichomoniasis, the most common curable sexually transmitted disease in the United States.