Bayer HealthCare announced that the FDA has approved Skyla, a new hormone-releasing intrauterine system for the prevention of pregnancy for up to three years. Skyla is a small, flexible plastic T-shaped device containing 13.5mg of levonorgestrel, a progestin hormone.
The approval of Skyla is supported by data from a multicenter, multinational, randomized open-label Phase 3 trial that included 1,432 women aged 18–35 years. The pregnancy rate calculated as the Pearl Index (PI) in women aged 18–35 years was the primary efficacy endpoint used to assess contraceptive reliability. The PI 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%.
Skyla’s T-body is 28mm x 30mm and the outer diameter of the placement tube is 3.8mm. Skyla 13.5mg will be available the week of February 11, 2013.
For more information call (800) 288-8371or visit www.bayer.com.