Bayer HealthCare submits marketing application for contraceptive patch in EU

Comtex News Network

Sep 22, 2012 (Datamonitor via COMTEX) --Bayer HealthCare has submitted an application for marketing authorization in the European Union for a new transparent low dose contraceptive patch, ethinylestradiol/ gestodene.

France will serve as the reference member state in the decentralized procedure for gaining marketing authorization in countries in the European Union.

The data from clinical studies, including 4,200 women worldwide, show that the new low dose contraceptive patch is an efficacious contraceptive with a good safety profile.

The contraceptive patch is small, round and transparent and contains 0.55 mg ethinylestradiol and 2.1 mg gestodene. It is applied once a week either to the abdomen, buttocks or outer upper arm where it delivers a steady, continuous dose of hormones over the 7- day application period.

The systemic exposure is the same as observed after daily administration of a combined oral contraceptive containing 0.02 mg ethinylestradiol and 0.06 mg gestodene. Each patch is replaced after seven days, and after three weeks, there is a hormone-free week.

"Once approved and launched, our contraceptive patch will provide an additional choice among contraceptive methods especially for women who are looking for an aesthetic, convenient weekly transdermal application with a low hormonal dose," said Dr Flemming Ornskov, chief marketing officer - strategic marketing general medicine at Bayer HealthCare Pharmaceuticals." Market research shows that more and more women prefer non-daily contraception and we as a market leader in female contraception are committed to meet the individual needs of women by providing a broad range of different types of contraceptives."

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