Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contracep...( Company to Discuss P...),Health

Company to Discuss Phase 3 Plans with FDA

PRINCETON, N.J., Sept. 3 /PRNewswire/ -- Agile Therapeutics, Inc., announced today that it successfully completed two key clinical trials in the development of the company's new, innovative low-dose, once-weekly, contraceptive patch, which the company refers to by its internal product code AG-200-15. The Phase 2b safety and efficacy study successfully met its primary endpoint of ovulation suppression, cycle control and safety. The pharmacokinetic (PK) study demonstrated estrogen levels comparable with the well-established, low-dose oral contraceptive, LEVLEN(R). There were no serious adverse events in either study. With the successful pharmacokinetic and Phase 2b safety and efficacy study results, the Company will discuss its Phase 3 plans for AG-200-15 with the Food and Drug Administration (FDA).

(Photo: http://www.newscom.com/cgi-bin/prnh/20080903/NEW034 )

Daniel R. Mishell, M.D., Professor in the Department of Obstetrics and Gynecology at the University of Southern California, and a member of Agile's Scientific Advisory Board, commented, "Successful completion of the Phase 2b safety and efficacy study is an important step forward in proving the safety and efficacy of Agile's important, new low-dose contraceptive patch. For years, OB/GYN's have been recommending low-dose oral contraceptives to their patients considering hormone-based contraceptives. If shown to be safe and effective, a low-dose, once-weekly contraceptive patch would be a natural and needed addition to the hormonal-based contraceptives and an alternative to once-daily oral contraceptives."

Thomas Rossi, Ph.D., Agile's President and Chief Executive Officer, commented on the top-line data, "The purpose of conducting these studies was to demonstrate that our product delivers an appropriate, low dose of estrogen, and an effective dose
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