The FDA’s approval of the supplemental New Drug Application (sNDA) was based on efficacy and safety data from the ongoing Phase 3 ACCESS IUS trial (n=1,751). The study showed Liletta was >99% effective in preventing pregnancy across a varied demographic with differing age, body mass index, parity, and race.
Liletta, a hormone-releasing system, was initially approved in February 2015 for the prevention of pregnancy for up to 3 years. It gained additional FDA approval in January 2016 for the single-handed inserter.
“IUDs are among the safest and most effective forms of contraception and are a critical tool in reducing unintended pregnancy. As a clinician, I appreciate that the clinical trial demonstrated Liletta’s safety and efficacy across a wide range of women, regardless of age, BMI and ethnicity,” said Dr. David Turok, Associate Professor, University of Utah Department of Obstetrics and Gynecology.
Liletta is supplied as a 52mg strength system as a single- or two-handed inserter.
For more information call (800) 678-1605 or visit Liletta.com.