Visanne (dienogest), a new endometriosis treatment from Bayer Schering Pharma, will be launched in European markets soon.
Visanne is a once-daily oral tablet containing dienogest 2 mg that has been developed specifically for the treatment of endometriosis.
Bayer Schering Pharma AG, Germany, has successfully completed the decentralized part of drug approval procedure in Europe for Visanne.
Clinical studies showed that Visanne (dienogest) relieves endometriosis pain with high efficacy and reduces endometriosis lesions.
Visanne (dienogest) is also safe and tolerable.
Bayer Schering Pharma plans to launch Visanne (dienogest) from the second quarter 2010 onwards, the company said in a press release.
“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,”explained Phil Smits, MD, Head of Bayer Schering Pharma’s Business Unit Women’s Healthcare.
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 for endometriosis GnRH analogue, can only be used for the short-term relief of symptoms associated with endometriosis, 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 and to be superior to placebo in reducing pain related to endometriosis.
Pain relief is sustained over time and includes dysmenorrhea-like pain, pre-menstrual pain, diffuse pelvic pain and dyspareunia.
Endometriosis is a common disease among women of reproductive age.Endometriosis is a chronic gynecological disease defined by presence of endometrium-like tissue outside the uterus, which induces a chronic, inflammatory reaction. The endometrium is a layer of mucous tissue, which lines the uterus cavity and undergoes hormone-dependent changes during the menstrual cycle. The prevalence is estimated to be around 5-10% in women of childbearing age. Lower abdominal and pelvic pain, cramping menstrual pains (dysmenorrhea), painful sexual intercourse (dyspareunia) and infertility are well recognized symptoms of endometriosis.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare.
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. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG.