FDA Accepts Extended Duration sNDA for Miudella Hormone-Free IUD

The US Food and Drug Administration (FDA) has accepted for review a supplemental new drug application (sNDA) seeking to extend the approved duration of MIUDELLA (copper intrauterine system) from 3 years to up to 6 years, according to Organon. A Prescription Drug User Fee Act action is expected during the second quarter of 2027.¹

MIUDELLA is a hormone-free intrauterine device (IUD) currently indicated to prevent pregnancy in women of reproductive potential for up to 3 years. Approved in February 2025, it was the first new hormone-free IUD approved in the US in more than 40 years. Organon, which acquired exclusive global rights to the device from Sebela Women’s Health in June 2026, anticipates making it commercially available in late 2026.¹

“If approved, MIUDELLA would offer up to six years of hormone-free contraception,” Juan Camilo Arjona Ferreira, MD, chief medical officer at Organon, said in the release.¹

FDA acceptance begins the agency’s review and does not establish that MIUDELLA is safe or effective for the proposed 6-year duration. Organon did not provide the longer-term efficacy and safety findings supporting the requested extension in its announcement.

Phase 3 Data Supported Initial Approval

MIUDELLA was evaluated in 3 US clinical trials involving 1904 women aged 17 to 45 years. The pivotal phase 3 study was a prospective, multicenter, single-arm, open-label trial conducted at 42 US centers, with contraceptive efficacy through 3 years—measured using the Pearl Index—as its primary endpoint.^1,2

Among 1397 participants aged 17 to 35 years included in the efficacy cohort, the first-year Pearl Index was 0.94 pregnancies per 100 woman-years (95% CI, 0.43-1.78). The cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60), corresponding to contraceptive efficacy of approximately 99%. Overall placement success was also approximately 99%.¹

The most common adverse reactions, reported in at least 5% of participants, included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, postprocedural hemorrhage, and dyspareunia. Across the 3 trials, 8.5% of participants discontinued MIUDELLA because of bleeding or pain during the first year, declining to 3.2% by year 3. Annual expulsion rates declined from 1.9% in the first year to 0.9% in the third year.¹

REMS Requires Training Before Insertion

The MIUDELLA label carries a boxed warning about complications associated with improper insertion, including perforation, infection, undiagnosed abnormal bleeding, pregnancy loss, and expulsion.

The device is available only through the restricted MIUDELLA Risk Evaluation and Mitigation Strategy program. Clinicians must enroll in the program and complete training on proper insertion before first use. Pharmacies and health care settings that dispense the device must also be certified and may dispense it only to certified clinicians.¹

MIUDELLA is contraindicated in patients with pregnancy or suspected pregnancy, uterine abnormalities that distort the uterine cavity, acute pelvic inflammatory disease, postpartum or postabortal endometritis within the previous 3 months, unexplained uterine bleeding, Wilson disease, and several other conditions.

If the sNDA is approved, MIUDELLA would provide a longer-duration hormone-free contraceptive option. The FDA review will determine whether the submitted evidence supports extending use beyond the currently approved 3-year period.

References

1. Organon. Organon announces US FDA has accepted for review a supplemental new drug application for MIUDELLA, a hormone-free intrauterine device. News release. Published September 14, 2026. Accessed September 14, 2026. https://www.biospace.com/press-releases/organon-announces-us-fda-has-accepted-for-review-a-supplemental-new-drug-application-for-miudella-a-hormone-free-intrauterine-device
2. Creinin MD, Gawron LM, Roe AH, et al. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2025;143:110771. doi:10.1016/j.contraception.2024.110771