Bayer Schering Pharma’s Visanne has been cleared for market launch in Europe as a new treatment option for endometriosis.
Visanne is a once-daily oral tablet containing dienogest 2mg, developed specifically for the treatment of endometriosis.
A dedicated clinical study programme has proven that Visanne relieves endometriosis pain with high efficacy, reduces endometriosis lesions and demonstrates a favourable safety and tolerability profile. Market launch of the product is planned from the second quarter 2010 onwards.
“With Visanne, we will be able to offer women a new treatment option which can reduce the substantial burden of endometriosis,” said Phil Smits, Head of Bayer Schering Pharma’s Business Unit Women’s Healthcare. “Surgical treatment of endometriosis is associated with high relapse rates, and many currently available medical therapy options have side effects which do not allow for long-term use.
“Patients often need to use different combinations of the available treatment options and even undergo repeat surgical procedures. There is therefore a high medical need for new treatment options.”
The current standard therapy, GnRH analogue, can only be used for the short-term relief of symptoms, as safety concerns such as decreased bone mineral density and side effects such as hot flushes limit its long-term use.
Visanne has been shown to be as effective as GnRH analogue. Pain relief is sustained over time (shown in a clinical study lasting 15 months) and includes dysmenorrhoea-like pain, pre-menstrual pain, diffuse pelvic pain and dyspareunia (painful sexual intercourse).
Endometriosis is a chronic gynaecological disease defined by the presence of endometrium-like tissue outside the uterus, which induces a chronic inflammatory reaction. Its prevalence is estimated to be around 5–10% in women of childbearing age.