In a Phase III trial of Agile Therapeutics' combination contraceptive patch, AG200-15, women were much less likely to miss days of contraception with the patch than with the birth control pill. The results were presented at Reproductive Health 2012.
In the study, 998 women used the patch and 330 used the birth control pill, and over the first 6 cycles of the study, there were significantly more cycles described as "perfect compliance" for the patch than for the pill. Also, in the group of women using the patch, compliance improved during the study, while in the group using the pill, compliance worsened.
Andrew Kaunitz of the University of Florida, the principal investigator, commented: "Noncompliance among contraceptive users is an ongoing challenge, as the effectiveness of a contraceptive can decrease if it is not used correctly. The once-weekly regimen of AG200-15 is intended to be simple to use correctly and we are encouraged to see that compliance was better with AG200-15 than with an oral contraceptive."
Agile has submitted the patch for approval in the U.S. and it has been accepted for filing by the FDA. The company hopes to get a response early next year. Birth control is a crowded market--Johnson & Johnson ($JNJ) has a patch on the U.S. and European markets (Ortho Evra), and Bayer submitted a patch for approval in September.
In 2010, Agile raised $45 million in a Series B round to fund the Phase III trials of its weekly contraceptive patch and its filing for approval. The money also allowed the company to advance AG1000, its progestin-only contraceptive patch for women who can't use estrogen, such as breastfeeding mothers, into Phase II trials.
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