A contraceptive patch developed by Agile Therapeutics was awarded FDA approval late Friday, clearing the way for a new birth control option to reach the market.
The Agile (NASDAQ: AGRX) product, called Twirla, deliver delivers a combination of hormones via a proprietary skin patch applied once a week. It’s the first FDA approved product for the Princeton, NJ-based company.
For Agile, the regulatory approval has been a long time coming. The company submitted applications for FDA review twice before, receiving rejections in 2013 and 2017. The 2017 rejection cited deficiencies in the manufacturing process and questions about the patch’s adhesion properties. The company says its resubmitted application in 2019 addressed both concerns. Last October, an FDA advisory committee voted 14 to 1, with one abstention, to recommend approval of the Agile patch.
Twirla can be worn on the abdomen, buttock, or upper torso—except for the breasts. It delivers two hormones, levonorgestrel and ethinyl estradiol. They’re the same hormones administered by a patch sold by Mylan (NASDAQ: MYL), but in a lower dose to avoid safety risks associated with high doses of ethinyl estradiol. The FDA’s approval of Twirla requires a warning on the product’s label alerting physicians and patients about higher cardiovascular risks in women who use hormonal contraceptives and also smoke. The label also warns that women who have a body mass index greater than 30 face a greater risk of venous thromboembolism if they use the product. The Mylan product carries a comparable label.
The FDA’s approval of Twirla requires Agile to conduct a post-marketing study that assesses the risk of venous thromboembolism and arterial thromboembolism. That study will compare new Twirla users to new users of other horomonal contraceptives. Agile will also conduct another study to assess the residual drug content and strength of its patch, as well as its adhesion.
Agile isn’t ready to launch its Twirla yet. The company says it will spend the first quarter of this year working with managed care systems and insurers to gain coverage of its product. In the second quarter, Agile will put a sales team in place and validate its manufacturing process. The company expects to begin shipping the product to wholesalers in the fourth quarter of 2020.