FDA

FDA OK’s new copper IUD

March 6, 2025

Brand name: Miudella

Generic name: copper intrauterine system

Manufacturer: Sebela Pharmaceuticals

Approval date: February 24, 2025

FDA approved Miudella (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. According to a manufacturer press release, Miudella is the first hormone-free, low-dose copper IUD to be approved by the FDA in over 40 years.

Miudella does not require loading by an HCP; it comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of 3.7 mm.

Efficacy

Approval was based on data from a multicenter, single-arm, open-label clinical trial (NCT03633799), which evaluated Miudella in postmenarcheal, premenopausal women 17 to 45 years of age (N=1601). The primary endpoint was contraceptive efficacy through 3 years of use, as measured by the Pearl Index (PI) in women 17 to 35 years of age.

Women enrolled in the study provided 12,493 evaluable 28-day cycle equivalents in the first year and 27,115 evaluable cycles over the three-year treatment period. The PI for Year 1 was based on 9 pregnancies and the cumulative 3-year pregnancy rate was based on 22 pregnancies that occurred after the onset of treatment and within 7 days after Miudella removal or expulsion.

The cumulative 3-year PI was 1.05 (95% confidence interval [CI], 0.66-1.60). PI by year were as follows:

• Year 1 PI: 0.94 (95% CI, 0.43-1.78)
• Year 2 PI: 1.60 (95% CI, 0.43-1.78)
• Year 3 PI: 0.60 (95% CI, 0.12-1.76)

Of 54 subjects who desired pregnancy after study discontinuation and provided follow-up information, approximately 74.1% conceived within 12 months after removal of Miudella. The majority of these individuals conceived within 4 months of removal and as early as the first week post-removal, demonstrating the reversibility of Miudella.

Safety

Most common adverse reactions (incidence ≥5%) are: heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, and dyspareunia.

Sources:

FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women’s Health Inc. Sebela Pharmaceuticals. 2025. https://sebelapharma.com/assets/media/FDA_Approval_Release.pdf

Miudella. Package insert. Sebela Pharmaceuticals. 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218201s000lbl.pdf