FDA Approves First Non-Hormonal Copper IUD in Over 40 Years
Miudella achieves similar efficacy to other available copper IUDs with less than half the dose of copper.
The FDA has approved the copper intrauterine system Miudella for the prevention of pregnancy in females of reproductive potential for up to 3 years, Sebela Pharmaceuticals said in a release.1 The decision makes the hormone-free, low-dose copper intrauterine device (IUD) the first to be approved in the United States in more than 40 years.
FDA Approves Miudella IUD For Prevention of Pregnancy / RFBSIP - stock.adobe.com
Miudella has a flexible frame made of the material nitinol, which allows for strategic placement due to its elastic properties. The device achieves similar efficacy to other available copper IUDs with less than half the dose of copper. It does not require loading by a healthcare professional, as it comes fully preloaded within a tapered, rounded tip inserter. Sebela said Miudella will be available later in 2025.
READ MORE: Pharmacists Can Play Important Role in Contraceptive Services
"Considering it has been 4 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," David K. Turok, MD, MPH, principal investigator on trials evaluating Miudella, said in a release.1 "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."
The approval of Miudella was based on positive data from 3 clinical trials, including a phase 3, prospective, multicenter single-arm open-label study. The study assessed the 3-year efficacy, safety, and tolerability of Miudella in 1620 patients aged 45 years or younger at 42 centers in the US. The primary efficacy outcome was Pearl Index—pregnancies per 100 person-years—through 3 years. Data from the study was published in the journal Contraception.2
Of the patients included in the study, 98.8% had a successful IUD placement. The study found that the pregnancy risk was about 1% per year for patients with Miudella. The Pearl Index at 1 year was 0.94 and the cumulative Pearl Index at year 3 was 1.05. The most common adverse events included bleeding and pain, which deceased over time. Over the 3 year study period, 15.4% of patients discontinued due to bleeding or pain. Additionally, there were 8 serious adverse events, including 5 ectopic pregnancies.
"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," Kelly Culwell, MD, head of research and development at Sebela Women's Health, said in a release.1 "Our innovative copper IUD Miudella offers effective pregnancy prevention using less than half the copper of the currently available copper-based IUD in the US, 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."
In the US, 10.5% of women of reproductive age use an IUD.3 Copper IUDs, which do not contain hormones, work by causing an immune response in the uterus that creates a toxic environment for sperm. They are the most popular, non-hormonal, long-acting, and reversible contraception method and work immediately after insertion.4 According to the American College of Obstetrics and Gynecology, long-acting reversible contraceptives, including IUDs, are the most effective contraceptive methods.1
READ MORE: Women's Health Resource Center
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