Actavis plc, a leading global pharmaceutical company and leader in women's health care, and Medicines360, a nonprofit women's health pharmaceutical company, announced that Liletta (levonorgestrel-releasing intrauterine system) 52 mg is now available in the US for use by women to prevent pregnancy for up to three years.

Liletta was approved by the US Food and Drug Administration (FDA) on February 26, 2015, based on the largest hormonal IUD trial conducted in the US, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS). Liletta is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy.

"The availability of Liletta marks another significant achievement in women's health," said Carolyn Westhoff, MD, M.Sc, Professor, Division Director, Family Planning and Preventive Services, Columbia University Medical Center. "It's critical that women have choices when it comes to their preferred contraception and I am pleased that I can offer my appropriate patients this new safe and effective option."

With the availability of Liletta, IUD-appropriate women, regardless of financial status and insurance coverage, can now access this new safe and effective IUD through Actavis and Medicines360's partnership. Liletta is now commercially available in doctor's offices in the US and through this groundbreaking partnership, at a lower price for public health clinics enrolled in the 340B Drug Pricing Programme.

"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," said Pamela Weir, chief operating officer, Medicines360. "Through this truly innovative partnership, women will now have an accessible, affordable option for effective, long-term contraception."

"Actavis is committed to the continued development and commercialization of safe and effective contraceptives to address unmet needs in women's health," said Bill Meury, president, Actavis Branded Pharma. "Liletta is a progestin-only intrauterine device with >99% efficacy demonstrated over 3 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."

Liletta is a small, flexible plastic T-shaped system which is 32 mm x 32 mm in size. It works to prevent pregnancy by slowly releasing levonorgestrel (LNG), a progestin, 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. Generally, Liletta can be inserted at any time if the provider is reasonably certain that the woman is not pregnant. While Liletta is intended for use up to three years, it can be removed by a healthcare professional at any time. Liletta can be replaced at the time of removal with a new Liletta, if continued contraceptive protection is desired.

The approval of Liletta is supported by the largest hormonal IUD trial (ACCESS IUS) conducted in the US designed to reflect the US population. This multicenter open-label clinical trial included 1,751 women aged 16-45 who received Liletta. In women 16 to 35, Liletta was found to be 99.45% effective in preventing pregnancy in women regardless of race, parity (previous births), or body mass index (BMI). The trial is ongoing to evaluate the use of Liletta for up to four, five and seven years.

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. Most women were Caucasian (78.4 per cent) or Black/African American (13.3 per cent); 14.7 per cent of women were of Hispanic ethnicity. Nearly 58 per cent of trial participants were nulliparous (had not previously given birth), the largest percentage of nulliparous IUD patients ever studied.

In an analysis of women who discontinued the study early, 97 per cent returned to menses within three months after Liletta was removed. Furthermore, in a group of women (n=68) trying to conceive, 87 per cent became pregnant within one year of removal. Additionally, some women were able to conceive as soon as two weeks after removal (12 days). Approximately 19 per cent of women treated with Liletta experienced amenorrhea (absence of menstruation) 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, which excluded women with a history of ectopic pregnancy who did not have a subsequent intrauterine pregnancy, was approximately 0.12 per cent per 100 woman-years.