Bayer Schering’s contraceptive patch enters phase III
pharmafile | May 5, 2009 | News story | Research and Development, Sales and Marketing |Â Â Bayer, sexual healthÂ
Bayer Schering is to start phase III trials of its new contraceptive patch and anticipates submitting the product for regulatory approval in 2012.
Around 3,300 women will be enrolled into two global studies to evaluate the patch's reliability from May 2009.
Phil Smits, Bayer Schering's head of Women's Healthcare, said the novel patch would be the smallest, lowest dosed and the only transparent patch for female contraception on the market.
"We are optimistic that these attributes will make it an attractive option for women seeking alternative routes of hormonal contraception," he added.
The patch combines low dosed ethinylestradiol (an estrogen hormone) and gestodene (a progestin hormone) that travel through the skin into the blood stream.
It is applied once a week, meaning women will wear three patches per cycle for 21 days with one week's break. Its simple administration may give it an advantage over the conventional pill, which must be taken daily, and encourage patient compliance.
Competition
Bayer's product will challenge the only currently available contraceptive patch from Johnson and Johnson's subsidiaries. It's known as Ortho Evra in the US, where it is marketed by Ortho-McNeil, and Evra in the UK, where it is marketed by Janssen-Cilag.
But Ortho Evra has received bad press since its launch in 2002 being associated with strokes and thrombosis. It has also been on the receiving end of lawsuits filed by women who suffered blood clots – court records show Johnson & Johnson has spent at least $68.7 million to settle cases.
The company has also run additional studies have investigated the drug, and Evra's label has been updated to reflect new data. The FDA says it is a safe method of contraception when used according to the labelling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.
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