Agile Therapeutics provides clinical update on Twirla, pipeline evaluation

Agile Therapeutics provided an update on the Twirla post-marketing studies and status of its ongoing evaluation of the Company’s pipeline. Twirla Post-Marketing Studies: As part of Twirla’s approval, the United States Food and Drug Administration required the Company to conduct a long-term prospective, multi-center clinical post-marketing requirement study comparing the risks of venous thromboembolism and arterial thromboembolism in new users of Twirla to new users of combined hormonal contraceptives and Ortho Evra generic patches. In January 2023, the FDA agreed with the Company’s proposal to address this PMR using electronic health records and insurance claims from a large database from multiple healthcare systems. The FDA also agreed to extend the study timelines. Under these new milestones, interim safety data reporting to the FDA is due in November 2029, and the final PMR study report is scheduled to be submitted to the FDA in November 2035. Status of Pipeline Evaluation: As previously disclosed, all work on Agile’s pipeline has been halted since 2021 as the Company concentrates its efforts the commercialization of Twirla. Commercializing Twirla remains the Company’s primary focus into 2023; however, the Company has continued to evaluate the potential eventual advancement of the AG200-15 Extended Regimen and the progestin-only patch. "Our primary focus since the launch of Twirla has been the commercial growth of Twirla. We believe, however, that we have potential value in our pipeline and have been evaluating how to prioritize the eventual development of our product candidates. While we do not currently expect to invest significant funds in our pipeline in 2023 as we continue to focus on maintaining capital efficiency and keeping tight control on our operating expenses, we have been using creative approaches to advance the evaluation of our pipeline and prepare for a time when we can move forward," stated, Al Altomari, Chairman and Chief Executive Officer of Agile Therapeutics.As part of its evaluation of the AG200-15 Extended Regimen, Agile performed an analysis with a simulated pharmacokinetic model that was used to predict the systemic levonorgestrel and ethinyl estradiol exposure of Twirla if used for twelve consecutive weeks. Data from a previously published clinical phase 1, open-label, randomized clinical trial2 was used for the PK model simulation, which included 36 healthy individuals who used a standard Twirla regimen for three consecutive weeks.