Bayer has submitted Visanne to regulators in Europe for the treatment of the chronic gynecological disease endometriosis.

The Leverkusen-based firm, which noted that the Netherlands will serve as the reference member state in its bid to get European-wide authorisation, said that in contrast to other drugs used presently, Visanne (dienogest) is an endometriosis-specific therapy for the long-term treatment of the disease. Bayer noted that the current standard therapy, with gonadotropin-releasing hormone analogues, is only suitable for short-term treatment due to severe side-effects.

Phil Smits, head of Bayer Schering Pharma´s women's healthcare unit, said that as endometriosis is a “long-lasting gynaecological condition that causes dramatic and recurrent pain, turning a woman's life upside down”, there is a need for an effective and well tolerated treatment that can be used over a long period of time. Visanne adresses this need, he said, as it has “the same efficacy as the current therapeutic standard but with significantly less side effects”.

The company claimed that Visanne's efficacy and tolerability have been proven in several clinical studies and to date, more than 700 women have been treated with the drug for up to 15 months. First data of the study were presented at the American Society for Reproductive Medicine in November last year and further data are planned for publication.