Organon, the Jersey City, New Jersey-based women’s health company, has opened enrollment in the Risk Evaluation and Mitigation Strategy (REMS) program for MIUDELLA, its hormone-free copper intrauterine system, ahead of the product’s anticipated commercial availability in late 2026. The program, live now at miudellarems.com, lets healthcare providers, care settings, and specialty pharmacies complete required training and certification before the device actually reaches patients.
Why This Product Needs a REMS in the First Place
A REMS program is an FDA-mandated safety framework that restricts how a product can be distributed or used when there’s a meaningful risk tied to improper handling. For MIUDELLA, that risk is insertion: as Organon puts it, “improper insertion of intrauterine systems, including MIUDELLA, increases the risk of complications.” Rather than let any provider prescribe and insert the device without documented training, Organon is requiring certification first. Juan Camilo Arjona Ferreira, Organon’s Head of Research & Development and Chief Medical Officer, framed opening the program early as a deliberate part of the launch sequence: “The REMS program for MIUDELLA establishes a consistent foundation for training and certification, helping to ensure the safe use of this new hormone-free IUD option. Making MIUDELLA REMS training and certification available ahead of product availability is a key milestone in our launch preparations, equipping healthcare providers, healthcare settings, and specialty pharmacy partners to offer and dispense MIUDELLA as a contraceptive option to patients when it becomes available in late 2026.”
What Actually Makes MIUDELLA Different
MIUDELLA is notable beyond the REMS mechanics: it’s the first hormone-free copper IUD to reach the U.S. market in more than 40 years, FDA-approved in February 2025 after Sebela Women’s Health developed it. The device uses proprietary SLIMSERT technology, a highly flexible frame paired with a fully preloaded inserter and a notably narrow 3.7mm insertion tube, designed to make placement easier than older copper IUD designs. It’s approved to prevent pregnancy for up to three years. In the Phase 3 trial of 1,397 women ages 17 to 35 — conducted by Sebela Women’s Health ahead of the drug’s 2025 FDA approval, the device delivered a first-year Pearl Index of 0.94, corresponding to about 99% effectiveness, a cumulative three-year Pearl Index of 1.05, and a placement success rate around 99%. The most common side effects reported were heavy menstrual bleeding, painful periods, and bleeding between periods.
How Organon Got the Rights
Organon doesn’t own MIUDELLA outright, it holds an exclusive global license from Sebela Pharmaceuticals, with the licensing agreement completed on June 22, 2026. Organon CEO Joe Morrissey described the appeal of adding a non-hormonal option to the company’s portfolio: “MIUDELLA represents an important hormone-free option in contraception, expanding choices for women seeking long-acting reversible birth control.” Sebela Pharmaceuticals CEO Alan Cooke explained why his company sought a partner rather than commercializing MIUDELLA on its own: “Organon offers the scale, launch readiness and access capabilities needed to bring this valuable product efficiently into clinical practice.” Opening REMS enrollment now, months ahead of the anticipated late-2026 launch, is a sign Organon wants provider certification largely cleared out of the way before the product actually needs to move off pharmacy shelves.
