Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced study initiation and dosing of the first patient in the Company's pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. AG200-15 is designed to effectively deliver a low dose of estrogen (ethinyl estradiol (EE)) in combination with levonorgestrel (LNG). The patch is applied once weekly for three weeks followed by a patch-free week.
“We are pleased with the progress of our lead AG200-15 program and the initiation of the pivotal, Phase 3 NEW CHOICE Study. We anticipate enrollment into the study will be rapid, driven by women's desire for greater convenience and ease of compliance in their choice of contraception.”
Agile's NEW CHOICE Study will enroll up to 1500 women aged 17-40 at over 100 sites throughout the U.S. The NEW CHOICE Study will compare efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive. Women interested in participating in the NEW CHOICE study should visit www.newchoicestudy.com.
Dr. Marie Foegh, Chief Medical Officer and Vice President, Clinical Research and Development of Agile Therapeutics, commented, "AG200-15 has been designed to maximize both safety and tolerability for women, delivering EE at a dose which can provide a favorable bleeding profile. Clinicians in fact have long experience with both EE and LNG, which have been used in contraceptive products for over 25 years. AG200-15 also incorporates Agile's novel SKINFUSION™ delivery system, offering additional advantages, including good adhesion and minimized irritation."
Dr. Thomas Rossi, Agile's President and CEO, stated, "We are pleased with the progress of our lead AG200-15 program and the initiation of the pivotal, Phase 3 NEW CHOICE Study. We anticipate enrollment into the study will be rapid, driven by women's desire for greater convenience and ease of compliance in their choice of contraception."
According to market research conducted on behalf of Agile with 105 OB/GYN physicians who are significant prescribers of contraception, 89 percent said they would be likely to prescribe AG200-15. Almost half said they would prescribe it immediately upon approval, demonstrating that physicians perceive a large need among their patients for the comfort and convenience of Agile's low-dose, weekly contraceptive patch. This physician data supports the findings of Agile market research with 1,500 women, where nearly two-thirds of the participants said they would ask their doctor about AG200-15 if it were available to them.
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