The U.S. Food and Drug Administration approved Agile Therapeutics Inc.'s hormonal contraceptive patch Twirla.
As part of the approval, the regulator is requiring Agile to conduct a long-term observational post-marketing study comparing the risks for venous thromboembolism and arterial thromboembolism in new users of Twirla to new users of other combined hormonal contraceptives.
Venous thromboembolism is defined as a blood clot that forms in the veins; arterial thromboembolism is a blood clot that forms in the arteries.
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 study to assess the residual drug content and strength of Twirla in a minimum of 25 women.
With two prior rejections citing adhesion and manufacturing concerns, the FDA extended the review period of the contraceptive on Nov. 14, 2019, after the company submitted additional data relating to its application.
Princeton, N.J.-based Agile said it plans to start shipping to wholesalers in the fourth quarter of 2020.