In February 2015, the US Food and Drug Administration (FDA) granted approval for Liletta based on the largest hormonal IUD trial conducted in the US, A Comprehensive Contraceptive Efficacy & Safety Study of an IUS (ACCESS IUS).
The multicenter open-label clinical trial included 1,751 women aged 16 to 45 years who received Liletta.
Liletta is a small, flexible plastic T-shaped system which is 32mm x 32mm in size and works to prevent pregnancy by slowly releasing levonorgestrel, a progestin, to prevent pregnancy, at an initial release rate of 18.6 mcg/day with an average in vivo release rate of LNG of about 15.6 mcg/day over a period of three years.
Medicines360 chief operating officer Pamela Weir said: "The commercial availability of Liletta represents a remarkable next step for women’s health in the US, providing IUD-appropriate women, regardless of income and insurance coverage, with a safe and effective contraceptive option.
"Through this truly innovative partnership, women will now have an accessible, affordable option for effective, long-term contraception."
Actavis Branded Pharma president Bill Meury said: "Actavis is committed to the continued development and commercialization of safe and effective contraceptives to address unmet needs in women’s health.
"Liletta is a progestin-only intrauterine device with >99% efficacy demonstrated over three years. Our groundbreaking partnership with Medicines360 will provide increased access to this novel IUD to women across the private and public healthcare systems in the US."