LILETTA: A New Long-Acting Reversible Contraceptive for Women in the U.S.

Strategic Insights -

LILETTA, a levonorgestrel-releasing intrauterine system (IUS) approved by the U.S. Food and Drug Administration (FDA) in February 2015, has been made available in the U.S. market for use by women to prevent pregnancy for up to three years. Developed by Actavis plc, a leading global pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, LILETTA is designed to work by continuously releasing levonorgestrel, a progestin, to prevent pregnancy. This new contraceptive option is now available in doctor's offices in the U.S. and through a partnership between Actavis and Medicines360, at a lower price for public health clinics enrolled in the 340B Drug Pricing Program.

Key Takeaways:

  • LILETTA was approved by the FDA on February 26, 2015, based on the largest hormonal IUD trial conducted in the U.S.
  • LILETTA is a progestin-only intrauterine device (IUD) with 99% efficacy demonstrated over 3 years.
  • The device is placed in the uterus by a healthcare professional and works to prevent pregnancy by slowly releasing levonorgestrel at an initial release rate of 18.6 mcg/day with an average in vivo release rate of LNG of approximately 15.6 mcg/day over a period of three years.
  • LILETTA is now commercially available in doctor's offices in the U.S. and through a partnership between Actavis and Medicines360, at a lower price for public health clinics enrolled in the 340B Drug Pricing Program.
  • The availability of LILETTA represents a significant achievement in women's health, providing women with choices when it comes to their preferred contraception.
  • The approval of LILETTA is supported by a large clinical trial (ACCESS IUS) that included 1,751 women aged 16-45, with a BMI range of 15.8kg/m2 - 61.6kg/m2 (26.9 kg/m2 mean BMI) across women of various races and ethnicities.
  • LILETTA was studied in women aged 16-45, with a BMI range of 15.8kg/m2 - 61.6kg/m2 (26.9 kg/m2 mean BMI) across women of various races and ethnicities.
  • Approximately 19 percent of women treated with LILETTA experienced amenorrhea within one year of treatment and more than one-third experienced amenorrhea by the third year of treatment.
  • The incidence of ectopic pregnancy in the clinical trial with LILETTA was approximately 0.12 percent per 100 woman-years.

Statistics:

  • 99% efficacy demonstrated over 3 years.
  • 1,751 women aged 16-45 participated in the ACCESS IUS clinical trial.
  • 78.4 percent of trial participants were Caucasian, 13.3 percent were Black/African American, and 14.7 percent were of Hispanic ethnicity.
  • The clinical trial included women with a BMI range of 15.8kg/m2 - 61.6kg/m2 (26.9 kg/m2 mean BMI).
  • Women experienced amenorrhea at the following rates: 19 percent within one year of treatment and 36 percent by the third year of treatment.

Sources:

  • Actavis plc. (n.d.). LILETTA: A Revolutionary Long-Acting Reversible Contraceptive. Retrieved from
  • Medicines360. (n.d.). LILETTA. Retrieved from
  • U.S. Food and Drug Administration. (2015, February 26). Actavis Receives FDA Approval for LILETTA, a Levonorgestrel-Releasing Intrauterine System for Contraception. Retrieved from