FDA Clears First One-Dose OTC Thrush Therapy

Bristol-Myers Squibb has been granted marketing clearance from the USFood and Drug Administration for the over-the-counter use of Vagistat-1 ointment (tioconazole 6.5%) for vaginal yeast infections.

This is the first one-dose medication for this indication to be approved for use without a prescription, says the company, and it represents the first prescription-to-OTC switch for B-MS. The company filed an application for the switch in November 1995, said a spokeswoman.

All other OTC products for vaginal yeast infections require three or seven days of treatment to be effective, which reduces patient compliance, B-MS says. This new one-dose formulation will ensure that the woman receives the full course of therapy needed for effective treatment. In clinical trials involving 1,060 patients with vaginal yeast infection, the most common side effects were burning and itching, which occurred in 6% and 5% of patients respectively.