The U.S. Food and Drug Administration (FDA) has approved Bayer’s new oral contraceptive SafyralTM which is the second in Bayer’s oral contraceptive portfolio containing folate. In women who choose an oral contraceptive (OC) for birth control, Safyral raises folate levels with the aim of reducing the risk of a
neural tube defect (NTD) in a pregnancy conceived while taking Safyral or shortly after discontinuing it. Safyral combines the hormone ingredients of the birth control pill Yasmin® (drospirenone/ethinyl estradiol) with Metafolin®*, a stable form of naturally occurring folate predominantly found in food. Folates belong to the group of B vitamins. In bSeptember 2010, the FDA approved BeyazTM, the first OC containing folate.
“Combining oral contraceptives with folate supplementation is an important contribution to existing measures for raising folate levels to reduce the risk of neural tube defects,” said Dr. Flemming Oernskov, Head of General Medicine at Bayer Schering Pharma AG. “With the approval of Safyral, we now offer women a choice of two OCs containing folate.”
neural tube defect (NTD) in a pregnancy conceived while taking Safyral or shortly after discontinuing it. Safyral combines the hormone ingredients of the birth control pill Yasmin® (drospirenone/ethinyl estradiol) with Metafolin®*, a stable form of naturally occurring folate predominantly found in food. Folates belong to the group of B vitamins. In bSeptember 2010, the FDA approved BeyazTM, the first OC containing folate.
“Combining oral contraceptives with folate supplementation is an important contribution to existing measures for raising folate levels to reduce the risk of neural tube defects,” said Dr. Flemming Oernskov, Head of General Medicine at Bayer Schering Pharma AG. “With the approval of Safyral, we now offer women a choice of two OCs containing folate.”
The Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, the March of Dimes and other leading health authorities recommend that all women of childbearing age supplement their diet with at least 400 mcg of folic acid daily.
A well-established body of evidence supports folate supplementation as a means to reduce the risk of neural tube defects – birth defects of the brain and spinal cord. Folate supplementation is particularly important at least one month before and three months
after conception.
after conception.
Women who discontinue OCs or do not take them correctly may become pregnant before seeking preconception counseling from their healthcare provider until after they become
For use outside the US only FDA approves Bayer’s new oral contraceptive SafyralTM
Oral contraceptive raises folate levels, reducing the risk of neural tube defects pregnant. Therefore combining an oral contraceptive with folate is a significant medical advance.
For use outside the US only FDA approves Bayer’s new oral contraceptive SafyralTM
Oral contraceptive raises folate levels, reducing the risk of neural tube defects pregnant. Therefore combining an oral contraceptive with folate is a significant medical advance.
Safyral is in a 21/7 day regimen consisting of 21 days of drospirenone 3 mg/ethinyl estradiol 30 mcg with Metafolin® (451 mcg levomefolate calcium) followed by seven days of Metafolin only. Safyral is expected to be available in the U.S. in mid-January 2011 by prescription only.
About the Clinical Development Program for Safyral
The FDA approval of Safyral, as well as of Beyaz, to raise folate levels in women who choose an OC for contraception are based on two pivotal studies.
A 24-week clinical trial involving 379 healthy women aged 18-40 years, which found that YAZ® (drospirenone/ethinylestradiol) in combination with 451 mcg of Metafolin increased folate levels from baseline. This multicenter, randomized, double-blind, parallel group study conducted in a U.S. population with folate fortified food evaluated the effect of YAZ in combination with 451 mcg of Metafolin on red blood cell (RBC) folate and plasma folate levels compared to YAZ alone during 24 weeks of treatment. At week 24, the mean
changes from baseline were significantly (p<0.0001) higher for women who took YAZ in combination with 451 mcg of Metafolin, as compared to women who took YAZ alone, for RBC folate (420 ± 347 nmol/L vs. 34.3 ± 171 nmol/L, respectively) and plasma folate (15.8 ± 20.4 nmol/L vs. -2.2 ± 14.6 nmol/L, respectively) levels.
The FDA approval of Safyral, as well as of Beyaz, to raise folate levels in women who choose an OC for contraception are based on two pivotal studies.
A 24-week clinical trial involving 379 healthy women aged 18-40 years, which found that YAZ® (drospirenone/ethinylestradiol) in combination with 451 mcg of Metafolin increased folate levels from baseline. This multicenter, randomized, double-blind, parallel group study conducted in a U.S. population with folate fortified food evaluated the effect of YAZ in combination with 451 mcg of Metafolin on red blood cell (RBC) folate and plasma folate levels compared to YAZ alone during 24 weeks of treatment. At week 24, the mean
changes from baseline were significantly (p<0.0001) higher for women who took YAZ in combination with 451 mcg of Metafolin, as compared to women who took YAZ alone, for RBC folate (420 ± 347 nmol/L vs. 34.3 ± 171 nmol/L, respectively) and plasma folate (15.8 ± 20.4 nmol/L vs. -2.2 ± 14.6 nmol/L, respectively) levels.
The addition of folate to an OC was further evaluated in a separate European study, which looked at Yasmin® in combination with either 451 mcg of Metafolin or 400 mcg of folic acid for 24 weeks, followed by 20 weeks of treatment with Yasmin only (no folate intake). This study found that the Metafolin treatment produced maximum mean increases in plasma folate (33.5 ± 14.5 nmol/L) and in RBC folate (782 ± 260 nmol/L) levels at 24 weeks. Upon discontinuation of folate intake, the average RBC and plasma folate levels gradually decreased to starting levels (or baseline) over 20 weeks.
Women who stop taking Safyral should be advised about maintaining folate
supplementation.
Women who stop taking Safyral should be advised about maintaining folate
supplementation.
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