FDA approves Twirla weekly application contraceptive patch.-Agile Therapeutics

Agile Therapeutics, Inc., a women’s healthcare company, announced that the FDA has approved Twirla (levonorgestrel and ethinyl estradiol) transdermal system. Twirla is designed for weekly application to deliver a 30 mcg daily dose of ethinyl estradiol, a type of estrogen, along with a 120 mcg daily dose of levonorgestrel, a well-known progestin with a long history in the category. The newly approved patch can be worn on the abdomen, buttock, or upper torso (excluding the breasts). As part of Twirla’s approval, the FDA is requiring Agile to conduct a long-term prospective, observational post-marketing study comparing the risks for venous thromboembolism (VTE) and arterial thromboembolism (ATE) in new users of Twirla to new users of other combined hormonal contraceptives (CHC). The FDA’s requirement for Twirla is similar to another post-marketing study requirement for a recently approved CHC. The final study report for the Twirla study is scheduled to be submitted to the FDA in November 2032, with interim safety data reporting to the FDA due in November 2026. Agile has also agreed to a post-marketing commitment (PMC) study to assess the residual drug content and strength of Twirla in a minimum of 25 women, which will analyze the Twirla ethinyl estradiol and levonorgestrel content after the prescribed wear and will monitor adhesion. The PMC is similar to residual drug studies requested of patch developers in the FDA’s November 2019 draft guidance entitled Transdermal and Topical Delivery Systems – Product Development and Quality Considerations. The Company plans to begin designing the post-approval studies and evaluating related costs during the first half of 2020. Comment: The FDA imposed a limitation of use for physicians to consider Twirla's reduced effectiveness in women with a BMI > 25 to < 30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI > 30 kg/m2.