Bayer Schering Pharma AG, Germany, and Bayer Yakuhin, Ltd., Japan, announced that the Japanese regulatory authorities have granted approval for YAZ (3 mg drospirenone/20 mcg ethinyl estradiol) for the treatment of dysmenorrhoea.
There are 27 million women of reproductive age in Japan, and one third of them are recognized to have menstrual pain, which can be related to dysmenorrhoea and requires some form of medical intervention. The introduction of this new treatment will contribute to improving women´s quality of life and offer a new option to respond to unmet medical needs.
YAZ is available in the US, Europe, Latin America and the region Asia Pacific. In the US and several other countries in various regions, it is approved as an oral contraceptive as well as for the treatment of the symptoms of Premenstrual Dysphoric Disorder (PMDD) and/or moderate acne vulgaris in women desiring oral contraception.
Menstrual disorders, especially dysmenorrhoea and premenstrual syndrome, are considered to affect the quality of life (QOL) of women during reproductive age. When the symptoms are severe, social activity is very limited during menstruation, reducing women’s QOL.
Depending on the pathogenesis, dysmenorrhoea is classified into primary dysmenorrhoea and organic dysmenorrhoea whereby primary dysmenorrhoea is more common. The symptoms of dysmenorrhoea usually begin at the start of menstruation, continue for a few days, and are characterized by pain that radiates from the lower abdomen to the inner thighs. Common associated symptoms include nausea and vomiting, diarrhoea, headache, fatigue, and irritability. Dysmenorrhoea can also be accompanied by dizziness and collapse.
YAZ contains the innovative progestin drospirenone. Drospirenone exhibits unique antimineralocorticoid and antiandrogenic properties, unlike any other progestin available in estrogen/progestogen combination products such as oral contraceptives. YAZ has a dosing regimen of 24 days of active hormone pills and four days of placebo. This innovative regimen combined with drospirenone’s benefits can reduce typical monthly hormonal fluctuations.
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.