Agile Therapeutics Provides Regulatory Update on Twirla for the Prevention of Pregnancy

Agile Therapeutics (Nasdaq:AGRX), a women’s healthcare company, today announced the content of the official minutes from its Type A meeting with the U.S. Food and Drug Administration (FDA) held on April 16, 2018 to discuss the complete response letter (CRL) issued by the FDA on December 21, 2017 relating to the New Drug Application (NDA) for Twirla (AG200-15), the Company’s investigational low-dose, non-daily, combination hormonal contraceptive patch.

As quoted in the press release:

In the official minutes, the FDA informed the Company that it continues to have significant concerns regarding the adhesion of Twirla, which the FDA believes cannot be addressed through the Company’s proposed patient compliance programs, and that the Company needed to address the Twirla adhesion properties by reformulating the transdermal system and conducting a formal adhesion study with the new formulation. The FDA also informed the Company that it would need to demonstrate bioequivalence to the data and information for the original formulation.  The FDA advised the Company that after the Company satisfies the FDA’s questions on adhesion and adequately bridges to the findings in the SECURE Phase 3 trial, it anticipates discussing the safety and efficacy of Twirla at an advisory committee meeting to obtain input on whether the benefits outweigh the risks.

Click here to read the full press release.