FDA approves Safyral, an oral contraceptive that raises folate levels

Bayer HealthCare announced the approval of Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), an oral contraceptive that raises folate levels in women who choose an oral contraceptive for birth control. This approval was based on data from two clinical trials. The first was a U.S. multicenter, randomized, double-blind, parallel group study 24-week clinical trial involving 379 healthy women aged 18–40 years. Data showed Yaz (drospirenone 3mg/ethinyl estradiol 20mcg, from Bayer HealthCare) in combination with 451mcg of levomefolate calcium (Metafolin) to have increased folate levels significantly from baseline compared to Yaz alone: RBC folate (420 +/- 347nmol/L vs. 34.3 +/- 171nmol/L, respectively) and plasma folate (15.8 +/- 20.4nmol/L vs. -2.2 +/- 14.6nmol/L, respectively).

A separate European study which looked at Yasmin (drospirenone 3mg/ethinyl estradiol 30mcg, from Bayer HealthCare) in combination with either 451mcg of Metafolin or 400mcg of folic acid for 24 weeks, followed by 20 weeks of treatment with Yasmin only, found that the Metafolin treatment produced maximum mean increases in plasma folate (33.5 +/- 14.5nmol/L) and in RBC folate (782 +/- 260nmol/L) levels at 24 weeks.

Safyral is a 21/7 day regimen containing drospirenone 3mg/ethinyl estradiol 30mcg/levomefolate calcium 451mcg tablets plus levomefolate calcium 451mcg tablets. Safyral is expected to be available mid-January 2011.

 For more information call (800) 288-8371or visit www.safyral.com.