The US Food and Drug Administration approved a supplemental New Drug Application extending the labeled duration of use of the etonogestrel implant (Nexplanon) for pregnancy prevention from three years to up to five years, based on clinical trial data demonstrating continued contraceptive efficacy and no new safety findings during extended use. The approval applies to the radiopaque etonogestrel implant marketed by Organon.
The regulatory decision was supported by results from a multicenter, single-arm, open-label study conducted in the US that evaluated contraceptive efficacy and safety during years 4 and 5 of implant use. The study enrolled 399 women of reproductive potential who had been using the implant for approximately 36 months at enrollment. Participants had a mean age of 27 years, with an age range of 18 to 35 years, and reflected a broad range of body mass index (BMI) values, from 17.2 to 64.3 kg/m2. More than one-third of participants had a BMI of 30 kg/m2 or higher, including 10% with a BMI of at least 40 kg/m2.
The primary efficacy endpoint was the Pearl Index during years 4 and 5 of use. No pregnancies occurred during this period, resulting in a Pearl Index of zero pregnancies per 100 women-years of use. Researchers reported no new safety findings during extended use, and the adverse reaction profile observed during years 4 and 5 was consistent with that reported during the initial three years of use. Changes in menstrual bleeding patterns remained the most frequently reported adverse reaction leading to discontinuation.
As part of the approval, the agency required implementation of a Risk Evaluation and Mitigation Strategy (REMS) to mitigate complications associated with improper insertion and removal of the implant. Under the REMS program, the product will be available only through certified health care providers, pharmacies, and distributors that meet specific training and enrollment requirements. The program expands upon an existing controlled distribution and clinical training framework in place since 2006 and is intended to reduce risks such as deep insertion, migration, and difficulty with removal.
"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," noted Anita Nelson, MD, Professor of Obstetrics and Gynecology at Western University of Health Sciences.
Nexplanon is indicated for prevention of pregnancy for up to five years and does not protect against human immunodeficiency virus or other sexually transmitted diseases.
Source: Organon
