FDA clears Agile Therapeutics' Twirla weekly contraceptive patch

Agile Therapeutics said the FDA has approved its Twirla transdermal system, a weekly contraceptive patch that delivers a daily dose of ethinyl oestradiol, along with a daily dose of levonorgestrel. "Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate US women a weekly transdermal option that delivers oestrogen levels in line with labeled doses of many commonly prescribed oral contraceptives," commented David Portman, a primary investigator on the Phase III SECURE trial. 

The approval follows a recent FDA advisory panel that voted 14 to 1, with one abstention, that the benefits of Twirla, also known as AG200-15, in the prevention of pregnancy outweigh the risks. The patch is indicated for women with a body mass index (BMI) under 30 and can be worn on the abdomen, buttock or upper torso, excluding the breasts. The label comes with a boxed warning about how cigarette smoking raises the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. 

Agile says it will spend the first quarter of this year working with managed care systems and patient payors to gain coverage of its product. Starting in the second quarter, Agile will put a sales team in place and validate its commercial manufacturing process. The company expects to begin shipping the product to wholesalers in the fourth quarter of 2020. It added that it believes that the potential new CHC users who have a BMI under 30 "represent a significant population of women," with Twirla can potentially achieving a peak market share of 5% to 8%. 

Agile had filed the contraceptive patch twice before, receiving complete response letters in 2013 and 2017, the last of which cited deficiencies in the manufacturing process and questions about the patch's adhesion properties. The company said its resubmitted application in 2019 addressed both concerns, while an FDA decision originally expected last November was extended by three months. 

The single-arm SECURE trial, designed to evaluate Twirla in 2032 healthy women aged 18 years and over, was conducted to address issues raised by the FDA complete response letter in 2013, including ensuring that testing included a "representative sample" of US women who are seeking hormonal contraception, taking into account contraceptive user status, age, race, ethnicity and BMI. 

Meanwhile, the FDA's approval of Twirla requires Agile to conduct a post-marketing study that compares the risk of venous thromboembolism and arterial thromboembolism in new Twirla users to new users of other CHCs. Agile will also conduct another post-marketing study to assess the residual drug content and strength of its patch, as well as its adhesion. 

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