Bayer: Visanne Cleared In Europe For Endometriosis Treatment
Published by Admin on 2009/12/11 (800 reads)
FRANKFURT -(Dow Jones)- Bayer Schering Pharma AG has successfully completed the decentralized part of drug approval procedure in Europe for a new treatment of endometriosis called Visanne, the company said Monday.
MAIN FACTS:
-Visanne is a once-daily oral tablet containing dienogest 2 mg that has been 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.
-The current standard therapy (regarding efficacy), GnRH analogue, can only be used for the short-term relief of symptoms associated with endometriosis, as safety concerns 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 (shown in a clinical study lasting 15 months).
MAIN FACTS:
-Visanne is a once-daily oral tablet containing dienogest 2 mg that has been 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.
-The current standard therapy (regarding efficacy), GnRH analogue, can only be used for the short-term relief of symptoms associated with endometriosis, as safety concerns 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 (shown in a clinical study lasting 15 months).
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