Agile Therapeutics Inc (NASDAQ:AGRX) shares rose Monday after the company’s Twirla met its primary endpoint.
The women’s health-care company, based in Princeton, New Jersery, today announced topline results from a comparative wear study testing the adhesion of Twirla® compared to that of Xulane® (the "comparative wear study"), the generic version of the previously marketed Ortho Evra® contraceptive patch, a product the U.S. Food and Drug Administration (FDA) considers to have acceptable adhesion.
In the study, Twirla met its primary endpoint and demonstrated non-inferior adhesion to Xulane.
The Company conducted the comparative wear study as part of its plan to implement the recommendations of the FDA’s Office of New Drugs (“OND”) that were delivered to the Company in OND’s formal dispute resolution decision letter. OND recommended that the Company complete a comparative wear study as part of a potential path forward for seeking regulatory approval of the Twirla NDA.
Said Chief Medical Officer Elizabeth Garner, "We believe that the topline data from our comparative wear study provide important insights into the adhesion performance of Twirla that we can share with the FDA to support that Twirla demonstrates adequate in vivo adhesion.
"While the results from the study will need to be reviewed by the FDA as part of our planned NDA re-submission, we are very pleased with the results."
Shares in Agile grew 9.9 cents, or 9.5%, to 99 cents
