GlaxoSmithKline Receives European Approval for Prostrate Drug

• Date: March 31, 2010
• Source: Admin

March 31, 2010 is a day of joy for GSK as it receives EU approval via the Decentralised Procedure with Germany acting as Reference Member State for its prostrate drug, Duodart.

More on Duodart

Duodart is a fixed dose combination (FDC) of dutasteride and tamsulosin and promises to treat effectively the moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH). Dutasteride is currently marketed as Avodart and tamsulosin, known as Flomax, is a generic drug marketed by Astellas Pharma.

Duodart, the once-daily dose medicine to treat the condition, will reduce the risk of acute urinary retention (AUR) and surgery in patients with moderate-to-severe symptoms of BPH, says GSK.

During clinical trials, the combination therapy was well-tolerated and other than anticipated adverse effects such as erectile and ejaculatory dysfunction, any other effect has not been reported.

More on BPH

BPH, commonly known as prostate enlargement is a regular condition for men aged 51 and above.  Almost 40% men over the age of 65 suffer from the problem. Prostate enlargement takes place when its cells overgrow and start affecting the urine flow.

Men who have moderate BPH, experience symptoms interrupted sleep caused by nocturia, restricted daily activities caused by frequent and urgent need to urinate, anxiety, and fear of surgery and all these symptoms affect their quality of life, and also leave major adverse impact on close relationships.

However, GSK believes their medicine Duodart will successfully provide an impressive answer to minimize the problem of BPH.

Source:

http://www.pharmpro.com/News/FeedsAP/2010/03/gsk-receives-eu-approval-for-prostate-drug/

http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10036.htm