Viatris Presents Positive Phase 3 Data for Low-Dose Estrogen Contraceptive Patch at ACOG 2026
核心洞察
Viatris announced six data presentations on its investigational low-dose estrogen combined hormonal contraceptive weekly patch at the 2026 ACOG (搜索) Annual Clinical & Scientific Meeting.
The presentations include positive results from a Phase 3 study (NCT05139121) demonstrating favorable contraceptive efficacy and safety profile with strong patch adhesion performance.
The FDA has accepted the New Drug Application under the 505(b)(2) pathway with a PDUFA target action date of July 30, 2026.
Viatris Inc. announced that six abstracts on its investigational low-dose estrogen combined hormonal contraceptive (CHC) weekly patch will be presented at the 2026 American College of Obstetricians and Gynecologists (ACOG (搜索)) Annual Clinical & Scientific Meeting in Washington, D.C., May 1-3, 2026. The presentations will showcase positive results from the company's Phase 3 clinical program and provide new insights into the patch's performance characteristics.
Phase 3 Study Results Show Promise
The presentations will include positive results from the previously announced Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of Viatris' investigational low-dose estrogen CHC weekly patch. The multicenter, open-label, single-arm study demonstrated a favorable efficacy and safety profile and strong patch adhesion performance.
Additional presentations will highlight new data on the patch's adhesion profile under normal and extreme conditions, as well as pharmacokinetic data and cycle control information. These comprehensive data sets provide healthcare providers with detailed insights into the patch's clinical performance across various parameters.
Regulatory Progress and FDA Review
The U.S. FDA has accepted for review the New Drug Application (NDA) for Viatris' investigational low-dose estrogen CHC weekly patch. The NDA was accepted under the FDA's 505(b)(2) regulatory pathway, and the agency has assigned a target action date (PDUFA) of July 30, 2026.
The regulatory submission is supported by results from the Phase 3 study, which evaluated the safety and contraceptive efficacy of the investigational treatment. The 505(b)(2) pathway allows the company to reference existing safety and efficacy data while providing new clinical evidence for its specific formulation.
Addressing Unmet Medical Needs
The investigational treatment is a once-weekly transdermal contraceptive patch being developed for women of childbearing potential with a BMI below 30 kg/m² who are appropriate candidates for combined hormonal contraception and prefer a non-invasive, reversible option with a lower estrogen dose.
The investigational low-dose estrogen CHC weekly patch aims to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance. This investigational treatment option builds upon Viatris' established capability in transdermal drug delivery and represents a lifecycle advancement of the contraceptive patch, Xulane® (norelgestromin and ethinyl estradiol transdermal system) 150/35 mcg per day.
Conference Engagement and Educational Support
In complement to its scientific program, Viatris provided an independent educational grant for an educational symposium hosted by PRIME®, a nationally recognized continuing medical education platform. The symposium, titled "Contraceptive Considerations in the Modern Era: Navigating Non-Oral Options and Evolving Clinical Complexities," was held on Friday, May 1, from 6-7:30 p.m. ET at the Marriott Marquis Washington, D.C.
Viatris maintained a presence at booth #223 during the conference, providing opportunities for healthcare professionals to engage with company representatives and learn more about the investigational contraceptive patch program.