Bayer's Low-Dose Contraceptive Patch Approved By The EU
Bayer announced that it has won approval for its new, low-dose contraceptive patch (gestodene/ethinylestradiol) in the EU. The company expects the Health Authorities of the EU Member States to grant national approvals for its product soon.
Dr. Jörg Möller, member of the Bayer HealthCare Executive Committee and Head of Global Development, said, “The new contraceptive patch will provide women with an additional choice of a low dose contraceptive.”
Clinical studies data showed that the new low dose contraceptive patch demonstrated efficacy and a good safety profile. 4,200 women around the world participated in the studies.
The new, transparent contraceptive transdermal patch is intended for the inhibition of ovulation. The product is small and round containing 2.1 mg of gestodone and 550 micrograms of ethinylestradiol. Each patch releases 60 micrograms of gestodene and 13 micrograms ethinylestradiol into the skin every 24 hours.
The product is applied once a week on the abdomen, buttocks, or outer upper arm. It delivers a steady and uninterrupted dose of hormones over the week-long application regimen. Each product is replaced after seven days. After three weeks of use, the patient reaches a hormone-free week.
Systemic exposure is considered equal to oral doses after daily administration of an oral contraceptive combination containing 6-micrograms gestodene and 20-micrograms ethinylestradiol.
Dr. Ornskov earlier said market research indicated an increasing number of women preferred non-daily contraception. He said Bayer’s new contraceptive patch will provide additional contraceptive choices for women looking for aesthetic, convenient, weekly transdermal applications with a low, hormonal dose. Bayer remains committed to providing a broad range of different types of contraceptives, he said.
The company originally submitted an application for marketing approval of its transparent low dose contraceptive patch in the EU in 2012. The company selected France as the reference member state in the recently concluded decentralized procedure for marketing authorization in EU countries.