World News: 12:30 GMT Monday 11th February 2019. [Agile Therapeutics, Inc. via Globe Newswire via SPi World News]
PRINCETON, N.J., Feb. 11, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX), a women’s healthcare company, 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.
The comparative wear study design follows the 2018 ANDA Guidance for Assessment of Adhesion entitled . The study was a randomized, open-label, crossover adhesion study in healthy women aged 18 to 35 years with a Body Mass Index of less than 35 kg/m. Subjects were randomized to wear either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week. Eighty-three subjects were randomized; 79 subjects completed the study, and 77 subjects were included in the Per Protocol population used in the primary analysis. Investigators assessed patch adhesion for each day of wear and assigned the patch a daily score ranging from 0 (essentially no patch lift off skin) to 4 (complete patch detachment).
The primary endpoint for the study was the mean difference in adhesion scores between Twirla and Xulane. As agreed upon at the December 2018 Type A meeting with the FDA’s Division of Bone, Reproductive, and Urologic Products (“DBRUP”), Twirla was to be considered statistically non-inferior to Xulane if the upper 95% confidence limit of the mean difference was less than +0.15. The study met this non-inferiority criterion by demonstrating a mean difference of -0.25 and upper 95% confidence limit of -0.16.
Table 1 shows the results for the primary endpoint: the mean difference in adhesion scores between Twirla and Xulane. The mean difference in Twirla minus Xulane is -0.25. The mean adhesion score for Xulane is higher than the mean score for Twirla, producing a negative mean difference. The upper bound of the 95% confidence limit for the mean difference is -0.16, thus Twirla met the non-inferiority criterion of +0.15.
A graphic accompanying this announcement is available at .
No complete detachments of Twirla or Xulane occurred during the trial. The final study report, when complete, will contain additional analyses pertaining to secondary endpoints and safety data.
“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 adhesion. While the results from the study will need to be reviewed by the FDA as part of our planned NDA resubmission, we are very pleased with the results,” said Dr. Elizabeth Garner, Senior Vice-President and Chief Medical Officer of Agile. “We greatly appreciate the hard work and dedication from our clinical team and wish to thank the research professionals and staff at TKL Research, and most importantly, the women who participated in the trial.”
The Company plans to include the results of the comparative wear study along with additional information relating to the manufacture of Twirla in its response to the Complete Response Letter (“CRL”) it received in December 2017. The FDA has previously informed the Company that in connection with its review of the Twirla NDA, the FDA plans to bring the safety and efficacy of Twirla to an Advisory Committee. The Company also expects that the FDA will conduct a pre-approval inspection of the Company’s third-party manufacturer’s facility, which must be successfully completed prior to approval.
“We believe that the topline results from the comparative wear study enable us to respond to the adhesion questions raised by the FDA in the December 2017 CRL and in subsequent communications,” said Al Altomari, Chairman and Chief Executive Office of Agile. Mr. Altomari continued, “We are now focused on completing our plan to resubmit our Twirla NDA in the first half of 2019, which we believe will position us to receive a PDUFA date before the end of the year.”
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Xulane is a registered trademark of Mylan N.V., and Ortho Evra is a registered trademark of Johnson & Johnson.
SOURCE: Agile Therapeutics, Inc.
Globe Newswire: 12:30 GMT Monday 11th February 2019
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