Organon Receives FDA Approval to Extend NEXPLANON Use to Five Years, Expanding Long-Acting Contraceptive Options for Women
Organon a global healthcare company dedicated to improving women’s health outcomes, has announced a significant regulatory milestone with the approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application (sNDA) for NEXPLANON® (etonogestrel implant) 68 mg. This approval extends the duration of use of the contraceptive implant from three years to up to five years, offering women a longer-lasting, highly effective option for pregnancy prevention.
The FDA’s decision reflects strong clinical evidence supporting both the safety and efficacy of extended use and represents an important advancement in long-acting reversible contraception (LARC). NEXPLANON is indicated for use by women of reproductive potential and is a progestin-only contraceptive implant placed subdermally in the upper arm.
A Meaningful Advancement in Women’s Reproductive Health
The extension of NEXPLANON’s approved duration addresses a growing demand for reliable, low-maintenance contraceptive options that align with women’s diverse lifestyles, reproductive goals, and medical needs. Long-acting reversible contraceptives are widely recognized for their effectiveness, convenience, and high continuation rates compared with short-acting methods.
According to Organon, the newly approved five-year indication reinforces the company’s long-standing commitment to advancing inclusive and comprehensive women’s healthcare.
Today’s approval represents a meaningful step forward for women seeking a highly effective, long-acting contraceptive option,” said Juan Camilo Arjona Ferreira, MD, Head of Research and Development and Chief Medical Officer at Organon. “Extending the duration of use to five years, supported by robust clinical data and inclusive patient representation, underscores our commitment to innovation in women’s health.”
Clinical Evidence Supporting Extended Use
The FDA approval was based on results from a multicenter, single-arm, open-label clinical trial conducted in the United States to evaluate the contraceptive efficacy and safety of NEXPLANON during years four and five of use. The study enrolled 399 women who had already been using the implant for approximately three years at the time of enrollment.
Participants ranged in age from 18 to 35 years, with a mean age of 27 years. Importantly, the trial included women with a broad range of body mass index (BMI) values, from 17.2 to 64.3 kg/m², ensuring the data reflected real-world patient diversity. Over 38% of participants had a BMI of 30 kg/m² or higher, including individuals with obesity, a population often underrepresented in contraceptive research.
Throughout years four and five of implant use, no pregnancies were reported, resulting in a Pearl Index of 0.0 pregnancies per 100 women-years of use. Additionally, investigators observed no new safety concerns, and the adverse event profile remained consistent with that seen during the initial three years of use.
Addressing Diversity and Real-World Patient Needs
Healthcare professionals have welcomed the updated labeling, which reflects broader patient inclusion and real-world applicability. The study population included women from diverse racial and ethnic backgrounds, as well as those with varying weights and BMIs.
Dr. Anita Nelson, Professor of Obstetrics and Gynecology at Western University of Health Sciences, emphasized the importance of the updated label. “The revised NEXPLANON labeling mirrors the diversity of patients seen in everyday clinical practice—women across reproductive ages, those seeking a long-term option lasting up to five years, individuals who prefer an arm implant over an intrauterine device, and women across a wide range of body sizes.”
She also highlighted that the approval provides clinicians with greater confidence when counseling patients about long-term contraceptive choices.
Introduction of an Enhanced REMS Program
As part of the sNDA approval, the FDA also approved a new Risk Evaluation and Mitigation Strategy (REMS) for NEXPLANON in the United States. This program is designed to further reduce the risk of complications associated with improper insertion and removal of the implant.
While Organon has maintained a controlled distribution and clinical training program since 2006, the updated REMS introduces additional proactive measures. These include enhanced certification requirements for healthcare providers to ensure proper training in insertion and removal techniques.
Under the NEXPLANON REMS:
- Healthcare providers must complete specialized training and certification before prescribing and inserting the implant.
- Pharmacies must be certified and may only dispense NEXPLANON to trained providers.
- Wholesalers and distributors must be registered and may only distribute to certified entities.
These measures aim to reinforce best practices, improve patient safety, and minimize the risk of complications such as deep insertion, migration, or difficulty with removal.
Safety Profile and Key Considerations
NEXPLANON carries a boxed warning related to the risk of complications from improper insertion and removal. Proper training and adherence to recommended procedures are critical to minimizing these risks. If the implant is inserted too deeply or cannot be palpated after insertion, it may lead to unintended pregnancy or require complex medical procedures for removal.
Other potential risks associated with NEXPLANON include changes in menstrual bleeding patterns, which are the most common reason for discontinuation, as well as headaches, acne, weight gain, breast pain, and abdominal discomfort. Serious but less common risks include thromboembolic events, ectopic pregnancy, and complications related to implant migration.
NEXPLANON is contraindicated in women who are pregnant or suspected to be pregnant, those with a history of thromboembolic disorders, active liver disease, hormone-sensitive cancers such as breast cancer, or known hypersensitivity to any component of the implant.
Importantly, NEXPLANON does not protect against HIV or other sexually transmitted infections (STIs), and patients should be counseled accordingly.
Implications for Patients and Providers
The five-year indication has meaningful implications for both patients and healthcare providers. For patients, extended duration translates into fewer replacement procedures, reduced healthcare visits, and potentially lower long-term costs. For providers, the updated label offers greater flexibility in counseling and long-term family planning discussions.
Return to fertility after removal remains rapid, with ovulation potentially resuming within one to two weeks. This makes NEXPLANON a suitable option for women who desire both long-term contraception and the ability to conceive shortly after discontinuation.
About the Extended-Use Trial for NEXPLANON
The contraceptive efficacy of NEXPLANON during use from 3 to 5 years was evaluated in a multicenter, single-arm, open-label study (NCT04626596) conducted in the United States.1 A total of 399 women were evaluated, having a mean age of 27 years, ranging from 18 to 35 years, and having been using NEXPLANON for 36 months (± 2 weeks) from the date of insertion at the time of enrollment. Participants were 74.2% White, 16.8% Black/African American, 3.8% Asian, 1.3% American Indian or Alaska Native, 0.5% Native Hawaiian or Other Pacific Islander, and 3.5% multiple or missing races. The mean BMI was 29.4 kg/m2 (range: 17.2-64.3 kg/m2), and the mean weight was 78.7 kg (range: 40.8-180.8 kg). One hundred fifty-two participants (38.1%) had a BMI ≥30 kg/m2, including 40 participants (10.0%) with a BMI ≥40 kg/m2.
The primary efficacy endpoint was the Pearl Index (PI) at years 4 and 5. No pregnancies were reported during this period, resulting in a PI of 0.0 (95% CI: 0.00, 0.69) pregnancies per 100 women-years of use, and there were no new safety findings.1
About NEXPLANON REMS
A REMS is a strategy used by the FDA to manage known or potential risks associated with a product.2 To mitigate complications due to improper insertion and removal, the FDA is requiring the implementation of a REMS program for NEXPLANON. NEXPLANON will only be available in the US through the NEXPLANON REMS program, which is planned to be available starting on February 23, 2026. Providers will have six months to enroll in the program in order to maintain their access to NEXPLANON for insertion.
