Liletta Approved for Pregnancy Prevention for Up to 6 Years

The Food and Drug Administration has approved the use of Liletta (levonorgestrel-releasing intrauterine system; Allergan and Medicines360) for the prevention of pregnancy for up to 6 years. Previously, the progestin-containing intrauterine device was indicated for up to 5 years of use.

The approval was based on data from a phase 3, open-label trial (ACCESS IUS) evaluating the safety and efficacy of Liletta in nulliparous (n=1011) and parous females (n=740) of child-bearing potential who request long-term, reversible contraception. Results showed that Liletta was >99% effective in preventing pregnancy for up to 6 years in a diverse population of women (BMI range was 15.8 to 61.6kg/m²).

“This groundbreaking trial has given healthcare providers the ability to confidently offer women the option of pregnancy prevention for up to 6 years,” said Carolyn Westhoff, MD, MSC, chief of the Division of Family Planning, Sarah Billinghurst Solomon Professor of Reproductive Health, Department of Obstetrics and Gynecology, Professor of Population and Family Health and Epidemiology, Columbia University, and investigator in the ACCESS IUS study.

Liletta contains 52mg of levonorgestrel which is initially released at a rate of approximately 20mcg/day. This rate decreases progressively to approximately 8.6mcg/day after 6 years; the average in vivo release rate of levonorgestrel is approximately 14.3mcg/day over a period of 6 years. The intrauterine system must be removed by the end of the 6th year and can be replaced with a new one if continued contraception is desired.

For more information visit liletta.com.