Agile Therapeutics announced results today from a Phase 2 clinical study of AG200-15, Agile's weekly contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG). According to the clinical findings, AG200-15 provides a low daily dose of estrogen equivalent to 30 micrograms EE, similar to that in low-dose, oral contraceptive (OC) pills. The study findings were delivered in an oral presentation at the American Society for Reproductive Medicine (ASRM) 66th Annual Meeting.
“Previous studies have demonstrated that AG200-15 is well-tolerated with a favorable breakthrough bleeding profile, very low rates of irritation, and adhesion in real-world conditions over the 7-day period of application. Agile's patch is an elegant solution to meet the promise of contraceptive patch technology.”
AG200-15 incorporates Agile's proprietary SKINFUSION™ transdermal delivery technology and is applied once weekly for three weeks followed by a patch-free week. Earlier this October, Agile announced the completion of patient enrollment ahead of schedule in its pivotal, Phase 3 NEW CHOICE Study of AG200-15.
Dr. Marie Foegh, Chief Medical Officer and Vice President, Clinical Research and Development of Agile Therapeutics, stated, "The reported Phase 2 results demonstrate AG200-15 delivers a dose of estrogen sufficiently low to avoid increased risk of adverse events, but still effective in preventing unwanted episodes of breakthrough (nonscheduled) bleeding. We believe this innovation, delivering the right dose of estrogen in combination with levonorgestrel can address women's desire for greater safety, convenience and ease of compliance in their choice of hormonal contraception."
Al Altomari, Agile's President and CEO, commented, "The daily estrogen exposure demonstrated in the Phase 2 study confirms our estimates based on the dose-ranging studies performed earlier by Agile. This is the first head-to-head study with a contraceptive patch vs. an OC to demonstrate EE exposure comparable to a low dose OC. We have designed AG200-15 to answer the market need for a contraceptive patch that provides convenience and compliance, with a low-dose of estrogen."
Mr. Altomari continued, "Previous studies have demonstrated that AG200-15 is well-tolerated with a favorable breakthrough bleeding profile, very low rates of irritation, and adhesion in real-world conditions over the 7-day period of application. Agile's patch is an elegant solution to meet the promise of contraceptive patch technology."
Agile's Phase 2 open-label, crossover study compared the EE pharmacokinetic (PK) profile of AG200-15 to an oral contraceptive in healthy female volunteers. Thirty-two subjects were included in the analyses. The maximum plasma concentration level (CMax) was approximately 60% lower for AG200-15, and steady state concentration levels (Css) were 15%-20% lower for AG200-15 compared to a 35 microgram OC (P < 0.02). According to the oral presentation at ASRM, "Daily EE exposure with the novel, low-dose transdermal contraceptive delivery system AG200-15 is comparable with that of a low-dose OC." The daily dose of AG200-15 is approximately 30 micrograms EE and is well within the range reported for low-dose OCs.
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