Agile Therapeutics Inc (fka AGRX)

[XenaLives]

Long term study required:

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 The PMC is similar to residual drug studies requested of patch developers in the FDA’s November 2019 draft guidance entitled Transdermal and Topical Delivery Systems – Product Development and Quality Considerations.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.

With the approval of Twirla, Agile will accelerate its commercial activities. In the first quarter of 2020, Agile plans to initiate work with managed care and patient payors to gain market access for Twirla. Beginning in the second quarter of 2020, the Company plans to hire and train an initial sales team. In parallel with these activities, Agile plans to complete the validation of its commercial manufacturing process and expects to ship initial product to wholesalers in the fourth quarter of 2020. The Company believes that the potential new CHC users who have a BMI <30 kg/m2 represent a significant population of women. Based on the Company’s market research, analysis of the current and expected future U.S. contraceptive market, and review of other product launches in the category, the Company estimates that Twirla can potentially achieve a peak market share of 5-8%. As the Company prepares for the commercialization of Twirla, it will continue to analyze the contraceptive market and update its market research as it evaluates the commercial opportunity for Twirla.

https://www.biospace.com/article/releases/fda-approves-agile-therapeutics-inc-s-twirla-levonorgestrel-and-ethinyl-estradiol-transdermal-system-a-new-weekly-contraceptive-patch-delivering-a-30-mcg-daily-dose-of-estrogen-and-120-mcg-daily-dose-of-progestin/