Sebela Women’s Health, a part of Sebela Pharmaceuticals, has announced the US Food and Drug Administration (FDA) approval of the MIUDELLA intrauterine device (IUD).
MIUDELLA is a hormone-free copper IUD designed for pregnancy prevention. It has been designed to work for up to three years in females of reproductive potential.
This next-generation, low-dose IUD is said to be the first FDA-approved copper IUD in over 40 years in the US.
The MIUDELLA IUD is designed with a flexible nitinol frame, intended to provide effective pregnancy prevention.
According to Sebela Pharmaceuticals, the super-elastic nitinol frame allows for strategic copper placement, delivering similar efficacy to other copper IUDs while using less than half the copper content (175 mm²).
MIUDELLA is claimed to feature the smallest hormone-free flexible IUD frame in the US, measuring 32 mm horizontally and 30 mm vertically, with pre-cut retrieval strings.
It comes preloaded in a tapered inserter with a 3.7 mm insertion tube diameter, eliminating the need for manual loading by healthcare professionals during insertion.
Sebela Women’s Health research and development head Kelly Culwell said: “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, utilising 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 was evaluated in three clinical trials involving 1,904 women aged 17 to 45 in the US.
A Phase 3 multicentre, open-label study conducted across 42 centres assessed contraceptive efficacy through the Pearl Index, which measures pregnancies per 100 women annually.
In the Phase 3 efficacy cohort, the first-year Pearl Index score was 0.94, and the cumulative three-year Pearl Index score was 1.05, showing 99% contraceptive efficacy.
Placement success was high, with an overall rate of 98.8%, as reported by both clinicians and study participants.
The MIUDELLA IUD will be available through trained healthcare providers in the US by late 2025.
Along with MIUDELLA, Sebela Women’s Health is also advancing a next-generation hormonal IUD for contraception, currently in the late-stage clinical development phase.
Braintree Laboratories, a part of Sebela Pharmaceuticals, has developed and commercialised a range of prescription colonoscopy preparations and gastroenterology products. The company also has several late-stage gastroenterology programmes, including Tegoprazan.
