Sebela Women’s Health, a part of Sebela Pharmaceuticals, has received FDA approval for MIUDELLA, a hormone-free copper intrauterine system (IUS) for pregnancy prevention. The approval marks a significant milestone as MIUDELLA is the first hormone-free copper IUD to receive FDA approval in the United States in over four decades.
The device has been approved for the prevention of pregnancy in females of reproductive potential for up to three years and offers an alternative to hormonal contraceptives with a different design approach than existing options.
“Sebela Women’s Health is thrilled to be able to bring this hormone-free IUD option for birth control to women in the United States,” said Kelly Culwell, MD, Head of Research and Development, Sebela Women’s Health. “Our innovative copper IUD MIUDELLA offers effective pregnancy prevention using less than half the copper of the currently available copper-based IUD in the U.S., utilizing a small, flexible nitinol frame. We believe these and other features of MIUDELLA may help address barriers to use, while also providing women with the hormone-free option some prefer.”
MIUDELLA features a flexible frame made of nitinol, a material with super-elastic properties that enables strategic placement of copper. This design allows the device to achieve similar efficacy to the currently available copper IUD while using less than half the dose of copper (175mm²). The company highlights that MIUDELLA uses the smallest hormone-free flexible IUD frame available in the United States, measuring 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings.
Another distinguishing feature is that it comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of 3.7 mm, eliminating the need for healthcare professional loading before insertion.
“Considering it has been four decades since we’ve been able to offer women a new hormone-free IUD option, I find the clinical data supporting MIUDELLA efficacy and safety to be very exciting,” said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. “This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options.”
MIUDELLA was investigated in three clinical trials in the U.S. involving 1,904 women aged 17 to 45 years. The Phase 3 study conducted at 42 U.S. centers showed promising results, with a first-year Pearl Index (a measure of contraceptive efficacy defined as the number of pregnancies per 100 women over one year) of 0.94 and a cumulative 3-year Pearl Index of 1.05, equating to approximately 99% efficacy over the three-year period.
The clinical trials also reported a 98.8% placement success rate. The most common adverse events were similar to those seen with other IUDs, including heavy menstrual bleeding, dysmenorrhea, and intermenstrual bleeding, with the incidence decreasing over time. In the first year, 8.5% of participants discontinued due to bleeding or pain adverse events, which decreased to 3.2% by year 3. Expulsion rates were also low, ranging from 1.9% in year 1 to 0.9% by year 3.
The approval comes with a Risk Evaluation and Mitigation Strategy (REMS) requiring healthcare providers to undergo training on proper insertion techniques before using MIUDELLA.
The introduction of this new option for contraception is particularly significant given that 41.6 percent of pregnancies in the U.S. are unintended, according to CDC data cited in the release. The American College of Obstetrics and Gynecology guidelines identify long-acting reversible contraceptive (LARC) methods, including intrauterine devices, as among the most effective contraceptive methods available.
Sebela Women’s Health plans to make MIUDELLA available to patients through trained healthcare providers in the U.S. later in 2025.
