New low-dose oral contraceptive YAZ launched in Europe
24/4 dosing regimen has shown to reduce hormone fluctuations
Berlin – Bayer Schering Pharma´s YAZ® will be available across Europe as of September 2008. YAZ® is the first oral contraceptive containing 3 mg of the unique progestin drospirenone combined with 0.02 mg of ethinyl estradiol in a new dosing regimen of 24 days of active hormone tablets followed by 4 days of hormone-free tablets. With this new regimen, a new pill pack is started immediately on the day after the last hormone-free tablet was taken. In the U.S., where YAZ® has been available since 2006, women´s overall satisfaction with this new pill is very high and YAZ® is the fastest growing branded oral contraceptive in the U.S.
"Taking active pills for three additional days can result in a reduction of hormonal fluctuations which often occur with conventional 21/7 pills," said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma AG. "Women who usually experience hormone withdrawal symptoms such as headaches or cramps during the pill-free week should benefit from the unique features of drospirenone delivered in the innovative YAZ® regimen."
YAZ will be available in Germany, Netherlands, Czech Republic, Slovakia, the Alpine countries and Scandinavia as from beginning of September 2008 closely followed by Portugal, Finland, Ukraine, Baltics and others. More European countries will launch YAZ® by the end of the year or first and second quarters of 2009.
Bayer Schering Pharma submitted the Premenstrual Dysphoric Disorder (PMDD) indication for YAZ® in Europe in July 2008 and will also submit the acne indication to the European Health Authorities later this year.
In several major countries and regions throughout the world, including the U.S., Latin America, and Asia-Pacific, YAZ® is already registered in three different indications: oral contraception, treatment of the emotional and physical symptoms of Premenstrual Dysphoric Disorder (PMDD) and treatment of moderate acne in women seeking contraception.
About YAZ® Drospirenone, the unique progestin contained in YAZ®, has both anti-mineralocorticoid and anti-androgenic properties. It counteracts the water retention often seen when taking estrogens, thereby reducing the "bloated" feeling that many women experience especially when starting on the pill. Clinical studies have also shown that because of the anti-androgenic properties, pills containing drospirenone can help to improve women’s skin condition. Extending the treatment period of active pills from 21 to 24 days per cycle means that the period of the therapeutic effects of drospirenone is prolonged by 3 days, leading to a more pronounced effect of drospirenone. In addition, with a half-life of 30 hours, the beneficial effects of drospirenone extend into the pill-free period.