A healthy vagina is a happy vagina, thanks to Searle/Monsanto...
Searle's New, Once-Daily Flagyl ER (Metronidazole Extended Release Tablets) Receives FDA Clearance for Marketing
New Indication for Bacterial Vaginosis Approved
SKOKIE, Ill., Dec. 4, /PRNewswire/ -- A new, once-daily, oral drug delivery system containing 750 mg of metronidazole from Searle has been cleared for marketing by the U.S. Food and Drug Administration (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 (affecting 10-25 percent of women visiting OB/GYN clinics)(A) in the United States. BV is more prevalent than yeast infections (candidiasis).(B) Flagyl ER will be available to retail pharmacies in the first quarter of 1998.
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.
Flagyl ER, with a Searle-developed, patented drug delivery system, offers unique characteristics allowing it to accommodate 750 mg of drug in one dosing and to maintain coverage for 24 hours. The drug is the only systemic BV therapy available.
''Searle is pleased to offer patients and their health care providers an entirely new formulation and indication for this drug that makes possible the effective oral treatment of a potentially serious medical condition,'' said Joe Papa, Searle's president of U.S. Operations. ''Flagyl ER, we believe, offers a new formulation that can enhance patient care and continue to demonstrate the value that Flagyl has brought to millions of people since it was first introduced by Searle in the United States nearly 35 years ago,'' he added.
BV and Its Potential Consequences
Bacterial vaginosis results from a shift in bacteria from the normal state to a high concentration of anaerobic bacteria. The chief symptom noticeable to women is vaginal discharge, but physicians need to identify other signs or symptoms to reach a diagnosis. BV has been associated with several complications of pregnancy and surgery.
Researchers have shown a link between BV and pre-term delivery, low-birth- weight babies, and premature rupture of membranes (PROM) surrounding the fetus. A recent National Institutes of Health study, published in the December 28, 1995 edition of The New England Journal of Medicine, found that women who were diagnosed with BV in the second trimester were 40 percent more likely to deliver a pre-term, low-birth-weight baby. One study has indicated that BV may affect 12-22 percent of pregnant women.(C)
Patient Preference: Oral vs. Topical Therapies
A 1995 nationwide survey of 1,332 women conducted by Roper Starch Worldwide, Inc., indicated that a majority of women stated they preferred to take oral medication instead of a vaginal cream or gel for the treatment of a vaginal infection other than a yeast infection. Women who preferred to take an oral medication said they did so because they claimed it was easy to use, less messy and more convenient.
''These are all factors that can help enhance patient compliance,'' noted James McGregor, MD, professor, Department of Obstetrics and Gynecology, University of Colorado, Denver, CO.
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 the vaginal cream.(D)
Because metronidazole crosses the placental barrier and enters the fetal circulation rapidly, it should not be administered to pregnant patients during the first trimester.
Since animal reproduction studies are not always predictive of human response and because metronidazole is a carcinogen in rodents, the risks and benefits of metronidazole use in the second and third trimester of pregnancy should be carefully evaluated. In a small number of cases, Flagyl ER has been shown to cause nausea and vomiting, and may cause an adverse reaction if drinking alcohol during treatment or for three days post treatment.
The introduction of Flagyl ER further strengthens Searle's commitment to women's health care, a core therapeutic area for the company that Searle established 37 years ago through the introduction of the world's first oral contraceptive.
Searle is a wholly owned subsidiary of the Monsanto Company (NYSE: MTC - news), a research-based corporation that develops, manufactures and markets products and other health care solutions worldwide. For more information about the company, consult Searle's Internet web site searlehealthnet.com. |
