The study showed that women experienced mean decreases in length of bleeding and spotting episodes, the Princeton, N.J.-based company reported.
Women taking Twirla reported a gradual decrease in the mean total number of bleeding or spotting episodes from six days to 4.9 days over the course of one year. Withdrawal bleeding during the patch-free week went from 4.7 days at the start of the trial to 4.1 days after 12 months. The mean number of days of breakthrough bleeding also decreased, going from 6.3 days to 5.2 days.
Just 2.2% of women withdrew from the trial due to bleeding-related adverse events, the company reported.
“Women generally hope for contraceptive options that lessen bleeding and spotting over time,” Dr. Anita Nelson, of Access Essential Health in Los Angeles, Calif., said in prepared remarks. “This is an important factor that affects selection of and long-term continuation with hormonal contraception.”
Earlier this year, the FDA accepted Agile Therapeutics’ resubmitted new drug application for Twirla. The agency is slated to make a decision about the patch’s application by Dec. 26.
“The Secure trial comprised an ethnically diverse, real-world population, which is reflective of women who may select the Twirla patch as their contraceptive method, if approved by the FDA,” Dr. Elizabeth Garner, SVP & CMO, added. “We believe Twirla has the potential to be an important low-dose, non-daily birth control option for today’s modern woman.”