Shares of Agile Therapeutics Inc. (AGRX) got pounded in extended trading on Tuesday despite positive results from SECURE, the company’s phase III trial of its once-weekly contraceptive patch Twirla.
SECURE was conducted to address issues raised by the FDA in its 2013 Complete Response Letter to the company.
In the SECURE trial, the PEARL-index score of Twirla was 4.80 in subjects 35 years of age and under. The Pearl Index is the number of failures that will occur among 100 women using a contraceptive method for a year.
Johnson Johnson’s Ortho Evra patch, greenlighted in 2001, was the first transdermal contraceptive to be approved by the FDA. According to results presented by Johnson Johnson in 2011, Ortho Evra patch had scored 1.24 on the PEARL index in a controlled North American study and scored 0.88 in a controlled European/South African study.
However, Johnson Johnson discontinued the production of that