Organon (NYSE: OGN) has opened enrollment in the Risk Evaluation and Mitigation Strategy (REMS) program for Miudella, a copper intrauterine system, ahead of the product's anticipated commercial availability in late 2026.

Miudella is a hormone-free copper IUD indicated for pregnancy prevention in females of reproductive potential for up to three years. The REMS program requires two separate certifications before the device can be dispensed: one for individual healthcare providers and one for the healthcare setting where it will be administered.

Healthcare providers must complete training and certification through the REMS portal before inserting Miudella. Practices and healthcare settings that purchase, dispense, or administer the device must also obtain independent certification, even if a provider at that location is already certified. Only specialty pharmacies already contracted with Organon through its existing limited distribution network are eligible for REMS certification. Patients are not required to enroll in the program.

The REMS program was established to reduce the risk of complications from improper insertion, which can include perforation, infection, and expulsion.

"Making Miudella REMS training and certification available ahead of product availability is a key milestone in our launch preparations," said Juan Camilo Arjona Ferreira, Head of Research & Development and Chief Medical Officer at Organon.

Miudella received FDA approval in 2025, according to Sebela Pharmaceuticals, which originally developed the product. Organon holds an exclusive global license to commercialize it. In a Phase 3 clinical trial conducted at 42 U.S. centers involving 1,397 women aged 17 to 35, the first-year Pearl Index was 0.94 and the cumulative three-year Pearl Index was 1.05. The most common adverse reactions reported in trials included heavy menstrual bleeding, dysmenorrhea, and pelvic pain.

The most common adverse reactions reported in trials, occurring in at least 5% of participants, included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia.