FDA approves Skyla (Bayer)levonorgestrel-releasing intrauterine system for use as a Contraceptive

The FDA has approved a new low-dose hormone intrauterine device designed to prevent pregnancy, the first new device of its type in 12 years, according to Bayer AG.

The T-shaped polyethylene device, known as Skyla, is designed to prevent pregnancy for 3 years, during which time it releases a diminishing dosage of progestin. The proportion of women using long-acting reversible contraceptive methods such as an intrauterine device (IUD) climbed to 7.7 percent in 2009 up from 2.0 percent in 2002, according a 2012 study by the Guttmacher Institute, a reproductive health and rights organization based in New York.

Approval was based on a Phase III trial that included 1,432 women aged 18-35 who received Skyla, of which 38.8% (556) had not yet had a child. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries. The Pearl Index estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within seven days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96.The cumulative three-year pregnancy rate, based on 10 pregnancies, estimated by the Kaplan-Meier method was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%. Of Skyla-treated women, 21.9% discontinued the study treatment due to an adverse event.

The device was approved as Jaydress in the European Union in December 2012.