Full Press Release Details
JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON®(etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of NEXPLANON for up to five years, an extension of the previous three-year indication. During the clinical trial to assess the contraceptive efficacy and safety of extended use (years 4 and 5), no pregnancies were reported and there were no new safety findings.1Additionally, the study enrolled women with a range of body mass index (BMI) values (17.2 to 64.3 kg/m2), with 38.1% of them having a BMI ≥30 kg/m2.
“Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon’s women’s health franchise,” said Organon’s Head of Research and Development and Chief Medical Officer, Juan Camilo Arjona Ferreira, MD. “The sNDA approval of an extended duration up to five years, along with data about the use of NEXPLANON in women with varying BMIs, including women with overweight or obesity, is a testament to Organon’s commitment to inclusive and comprehensive women’s healthcare.”
In addition, this approval includes a new Risk Evaluation and Mitigation Strategy (REMS) program in the US to mitigate complications due to improper insertion and removal.2This REMS program will enhance Organon’s existing Clinical Training Program (CTP) and controlled distribution program, which has been in place since 2006, by instituting important proactive measures to certify providers in the proper insertion and removal of our product.See additional safety information below.
“The updated label for NEXPLANON reflects the diversity of patients we see every day—women throughout their reproductive ages, those seeking a long-acting option of up to five years, those who prefer birth control that goes in the arm rather than the uterus, and women across a wide range of BMIs,” said Anita Nelson, MD, Professor, Obstetrics and Gynecology at Western University of Health Sciences. “The REMS program builds on existing training requirements to ensure providers maintain the highest standards for insertion and removal, reinforcing confidence and best clinical practice.”
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.1A 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.2To 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.
If providers have questions, they can contact their Organon representative. They can also visitwww.NEXPLANONREMS.comor call the Organon Service Center at 1-844-674-3200. If patients have questions, they should contact their healthcare provider.
Indication
NEXPLANON®is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.
Selected Safety Information
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL
Improper insertion of NEXPLANON increases the risk of complications.
Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion.
Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS.
CONTRAINDICATIONS
WARNINGS and PRECAUTIONSRisk of Complications Due to Improper Insertion and Removal
Complications of Insertion and Removal
Broken or Bent Implants
NEXPLANON is available only through a restricted program under a REMS.
NEXPLANON REMS
Notable requirements of the NEXPLANON REMS include the following:
Further information is available atwww.NEXPLANONREMS.comand 1-833-697-7367.
Changes in Menstrual Bleeding Patterns
Ectopic Pregnancies
Thrombotic and Other Vascular Events
Ovarian Cysts
Carcinoma of the Breast and Reproductive Organs
Liver Disease
Elevated Blood Pressure
Gallbladder Disease
Carbohydrate and Lipid Metabolic Effects
Depressed Mood
Return to Ovulation
Fluid Retention
Contact Lenses
ADVERSE REACTIONSClinical Trial Experience
DRUG INTERACTIONS
Effects of Other Drugs on Hormonal ContraceptivesSubstances decreasing the plasma concentrations of hormonal contraceptives and potentially diminishing the efficacy of hormonal contraceptives:
Substances increasing the plasma concentrations of hormonal contraceptives:
Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors andnon-nucleoside reverse transcriptase inhibitors:
Effects of Hormonal Contraceptives on Other Drugs
USE IN SPECIFIC POPULATIONSPregnancy
Lactation
Pediatric Use
PATIENT COUNSELING INFORMATION
Before prescribing NEXPLANON, please read thePrescribing Information, including the Boxed Warning. ThePatient Informationalso is available.
About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.
Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more athttp://www.organon.comand follow us onLinkedIn,Instagram,X,YouTube,TikTokandFacebook.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations for the market potential for the five-year indication for NEXPLANON. Forward-looking statements may be identified by words such as “continue,” “forward,” “seek,” “strategy,” “commitment,” “mission,” “expect,” “future,” “believes,” “will,” “potential,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to grow the market for NEXPLANON as expected; expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the US or other governments; changes in US and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon’s customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and health care reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; an inability to fully execute on Organon’s product development and commercialization plans; manufacturing difficulties or delays; disruptions at the US Food and Drug Administration, the US Securities and Exchange Commission (the “SEC”) and other US and comparable foreign government agencies; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to Organon’s marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon’s products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov).
1Data available on request from Organon Professional Services-DAP (Marketing Operations), 30 Hudson St., Jersey City, NJ 07302. Please specify information package US-XPL-117854.
2Risk evaluation and mitigation strategies | REMS. US Food and Drug Administration. Updated May 20, 2025. Accessed September 10, 2025.https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems