FDA approves first new hormone-free copper IUD in over 40 years
Market previously dominated by Paragard since 1984
The US Food and Drug Administration (FDA) has approved a new non-hormonal intrauterine device (IUD), marking the first such approval in over four decades.
MIUDELLA®, developed by Sebela Pharma offers a novel alternative in long-acting reversible contraception, a market previously dominated by Paragard® since its approval in 1984.
The newly approved device is a copper intrauterine system (IUS) designed for up to three years of pregnancy prevention - a shorter-term alternative to Paragard.
Dr. Kelly Culwell, Head of Research and Development at Sebela Women’s Health said:
"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.
"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."
A 99% efficacy rate
The device was tested in three clinical trials across the US, involving 1,904 women between the ages of 17 and 45 years old. According to Sebela, the first-year Pearl Index — a measure of contraceptive effectiveness — was 0.94, with a cumulative three-year index of 1.05, indicating a 99% efficacy rate.
Beyond its efficacy, MIUDELLA has been designed to improve the user experience. Its small, preloaded inserter, which measures just 3.7mm in diameter, aims to facilitate an easier and less painful insertion process.
Professor David K. Turok, a principal investigator in the MIUDELLA trials, expressed optimism about the new product's potential impact.
"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," he said.
"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 introduction of MIUDELLA comes at a time when demand for non-hormonal contraceptive options remains strong. With approximately 41.6% of pregnancies in the US classified as unintended, expanding access to reliable and diverse contraceptive options is a pressing public health priority.
MIUDELLA® is set to become available in the US later in 2025 through trained healthcare providers. Its approval offers a long-awaited alternative for those seeking effective, hormone-free birth control with a shorter-term commitment than Paragard.