Bayer Schering’s Visanne Gets Launch Clearance In Europe

Bayer Schering Pharma (Bayer Schering) has completed the decentralised part of drug approval procedure in Europe for a new treatment of endometriosis called Visanne. Visanne is a once-daily oral tablet containing dienogest 2mg that has been developed specifically for the treatment of endometriosis.

The company said that a study programme showed that Visanne relieves endometriosis pain, reduces endometriosis lesions and demonstrates a favourable safety and tolerability profile. Market launch of the product is planned from the second quarter of 2010 onwards.

Additionally, Visanne has been shown to be as effective as GnRH analogue and to be superior to placebo in reducing pain related to endometriosis. Pain relief is sustained over time (shown in a clinical study lasting 15 months) and includes dysmenorrhea-like pain, pre-menstrual pain, diffuse pelvic pain and dyspareunia.

Phil Smits, head of business unit, women’s healthcare at Bayer Schering Pharma, said: “With Visanne, we will be able to offer women a new treatment option which can reduce the substantial burden of endometriosis. Surgical treatment of endometrosis 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.”