Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced the Company has completed patient enrollment in its pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. Agile's NEW CHOICE Study enrolled 1500 women at over 100 sites throughout the U.S. The study is comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive. The NEW CHOICE Study completed enrollment two months ahead of schedule, enabling Agile to plan for an earlier submission of the New Drug Application (NDA) for AG200-15 to the U.S. Food and Drug Administration (FDA).

Dr. Thomas Rossi, Agile's President and CEO, commented, "We are very pleased to complete enrollment in the NEW CHOICE Study ahead of schedule. The rapid enrollment rate, 1500 women in eight weeks, reflects a broad interest amongst contraceptive users for the convenience of a once weekly contraceptive patch. We look forward to the continued progress of AG200-15 and anticipate the expedited timeline will enable us to file for FDA approval earlier than previously anticipated."

Dr. Marie Foegh, Chief Medical Officer and Vice President, Clinical Research and Development of Agile Therapeutics, stated, "Physicians perceive a large need among their patients for the comfort and convenience of Agile's low-dose, weekly contraceptive patch, and we are very pleased to potentially make our patch available earlier than anticipated. We extend a special thanks to the investigators of the study. Without their commitment to and support of the study, we would not have been able to complete enrollment in two months." Agile is working with DSP Clinical Research to manage the NEW CHOICE Study.