Actavis, Medicines360 launch Liletta 52mg to prevent pregnancy for up to three years

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."