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FDA Approves New Hormonal IUD

FDA Approves New Hormonal IUD

Last week, the U.S. Food and Drug Administration approved another option for long-term reversible contraception in the form of a hormonal IUD to be marketed as Liletta, a trademark of Odyssea Pharma SPRL, an Actavis affiliate. This new intrauterine system uses the progestin levonorgestrel, 52 mg, and has been approved for use in women to prevent pregnancy for up to 3 years.

What's unique about this IUD is the partnership between the pharmaceutical company Actavis and Medicines360, a nonprofit women’s health pharmaceutical company. Through their collaboration, this new levonorgestrel-releasing intrauterine system will be available to all women regardless of income or insurance coverage. Not only will this new hormonal IUD be available in the United States commercially, it also will be available to public health clinics enrolled in the 340B Drug Pricing Program. The IUD is expected to enter the US market in the second quarter of 2015.

The approval of Liletta™ was based on the ACCESS IUS trial (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), the largest hormonal IUD trial conducted in the United States to date. The study was designed to reflect the US population, enrolling women aged 16 to 45 years, who were nulliparous (nearly 58%) or parous, and with BMI ranging from 15.8 kg/m2 to 61.6 kg/m2. The IUD was found to be safe and effective for up to 3 years with 99.45% efficacy. However, the study is ongoing to determine the safety and effectiveness of the IUD for up to 4, 5, and 7 years.

In an analysis of women who discontinued the study early, menses returned in 97% of women within 3 months after removal of the IUD. Also, in a group of women trying to conceive, 87% became pregnant within 1 year of removal, with some women able to conceive as soon as 12 days after removal. Amenorrhea occurred in approximately 19% of trial participants within 1 year of treatment, and more than a third experienced amenorrhea by the third year of treatment.

The incidence of ectopic pregnancy in the clinical trial for Liletta™, which excluded women with a history of ectopic pregnancy who did not have a subsequent intrauterine pregnancy, was approximately 0.12% per 100 woman-years.

The full Prescribing Information is available here

 
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