2015年11月23日星期一

Once contraception for 5 years! Bayer submitted a listing application of long-term intrauterine device

German pharmaceutical giant Bayer (Bayer) today announced that the European Union and the United States has been submitted to regulators listing application of new long-acting intrauterine device LCS-16, which is a new low-dose levonorgestrel releasing intrauterine system (LNG-IUS), placed directly in the uterus, can provide up to 5 years of contraception. LNG-IUS is one of the most effective long-term contraceptive methods, can be removed at any time, after removing the women can quickly return to normal fertility.
LCS-16 is a small flexible plastic T-shaped device, once placed in the uterus, can release a low dose of progestin levonorgestrel, can provide up to 5 years of contraception. LCS-16 after removal, women can quickly return to normal fertility.
Phase III clinical program LCS-16, involving countries from North America and Europe, 574 cases of nulliparous (nulliparous) and 878 cases of maternal (parous), the primary endpoint of the clinical program for the introduction of Pearl Index (Pearl Index, PI) Evaluation The contraceptive effect. Data show that, LCS-16 contraceptive efficiency of over 98.5%, 3-year Pearl index was 0.31, 5-year Pearl index was 0.29. Study, LCS-16 overall well tolerated, unexpected adverse events occurred.
In April this year, generics giant Actavis (Actavis) in the United States launched a new intrauterine drug delivery device (IUD) Liletta, placed into the uterus after, can provide up to three years of contraception. In IUS study in Phase III ACCESS, Liletta duration of three years effective contraception up to 99.45%, after using the body mass index and women (BMI) no significant change. Currently, the study continues to evaluate Liletta use up to four years, five years, seven years of contraceptive efficacy and safety.


( Bolise Co., Ltd. www.chemicalspharm.com )

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