The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Searle
Approval Status: Approved December 1997
Treatment for: bacterial vaginosis
General Information
Flagyl ER, a new, once-daily, oral drug delivery system containing 750 mg of metronidazole, has been approved for marketing by the FDA. Flagyl ER is an extended release formulation of the anti-infective agent, metronidazole. It is the first and only once-a-day oral medication approved for the treatment of bacterial vaginosis (BV), the most frequent form of vaginal inflammation in the U.S. With a recommended dosing regimen of one tablet taken orally daily for seven days, Flagyl ER offers an extended release system to ensure 24-hour therapeutic coverage.
Clinical Results
In controlled comparison studies against vaginal cream, Flagyl ER restored the pH and normal vaginal flora earlier than the comparator vaginal cream by one month post-therapy. The quality of life evaluation in these studies, using data from a general health questionnaire known as the SF-36, showed there was no statistical difference in tolerability between the new, systemic Flagyl ER and a vaginal cream.
Side Effects
Because metronidazole crosses the placental barrier and enters the fetal circulation rapidly, it should not be administered to pregnant patients during the first trimester.
