Twirla, from Agile Therapeutics, has been seeking marketing approval from the FDA since 2012.
The US Food and Drug Administration (FDA) will again reconsider the case for an investigational contraceptive patch.
Yesterday, Agile Therapeutics announced the FDA’s scheduled meeting of its Bone, Reproductive and Urologic Drugs Advisory Committee to review the New Drug Application (NDA) of low-dose combined hormonal contraceptive patch AG200-15 (Twirla).
The advisory meeting, scheduled for October 30, will assess the third tried NDA from Agile for the investigative patch. In December 2017, the FDA most recently submitted a Complete Response Letter (CRL) to the therapeutics company—repeating its response to a 2012 NDA for the same patch.
Both previous CRLs requested additional clinical data for the patch, which Agile initially provided in October 2017. The Twirla patch is supported by evidence from the 13-cycle, phase 3 SECURE trial, in which 2000-plus women of reproductive age across multiple treatment centers reported a 1.5-day reduction in unscheduled bleeding and spotting from the first to last cycle.
The findings also showed that scheduled periods of bleeding or spotting were reduced to an average of 3.1 — 3.7 days.
The patch contains active estrogen ingredient ethinyl estradiol (EE) and active progestin ingredient levonorgestrel (LNG), and is designed to be applied once weekly over 3 weeks—followed by 1 week without application.
At the time of the initial application and first CRL, Elizabeth Garner, MD, MPH, chief medical office of Agile, said the team was pleased with the SECURE trial results and its potential to set a “new standard for hormonal contraceptive studies.”
“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,” she said in a statement.
The advisory committee’s role in October may be critical as to whether the hormonal patch is finally accepted or again rebuffed when the FDA rules on its newest NDA on November 16.
Agile is again expressing optimism.
“We look forward to the October 30, 2019, meeting with the Advisory Committee, as well as to continuing our dialogue with the FDA about Twirla and the important data, which we believe supports its approval,” Al Altomari, chairman and chief executive officer of Agile, said in a statement this week. “This is another key step towards providing an important contraceptive option for women today.”