FDA Rejects AG200-15 (Agile Therapeutics) Hormonal Contraceptive Patch

The US Food and Drug Administration (FDA) has submitted a Complete Response Letter (CRL) in response to the New Drug Application (NDA) of AG200-15 (Twirla, Agile Therapeutics), an investigational low-dose combined hormonal contraceptive patch.

The patch was originally submitted for FDA approval in 2012, but Agile received a Complete Response Letter (CRL) in February 2013, which identified concerns about the therapy’s efficacy, and a request for more information about the quality as well as chemistry, manufacturing, and controls data.

Agile submitted a second NDA in June 2017, which was accepted by the FDA under the condition that it addressed the issues raised by the 2013 CRL.

The 2013 CRL also requested additional clinical data, which Agile provided for the FDA in October 2017. That data, from the multicenter, single-arm, open-label, 13-cycle phase 3 SECURE trial, involved more than 2000 women of reproductive age, and showed that unscheduled bleeding and spotting days per month was reduced by 1.5 days from Cycle 1 to Cycle 13.

Additionally, scheduled periods of bleeding/spotting periods lasted an average of 3.1 to 3.7 days.

"We are pleased with the results of the SECURE trial and believe our study may set a new standard for hormonal contraceptive studies,” Elizabeth Garner, MD, MPH, Chief Medical Officer of Agile Therapeutics, said in a statement at the time.

“Our study entry criteria resulted in the inclusion of a real-world study population, including women who have frequently been underrepresented in past contraceptive studies,” Garner said. “We believe the SECURE trial has generated valuable new data that will contribute to the evolving understanding of how co-morbidities such as obesity and other factors impact hormonal contraceptive effectiveness."