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news.Aeterna Zentaris has said its initial new drug application of cetrorelix for patients with enlarged prostate has been accepted by the FDA.
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The company plans to initiate its phase III program before year-end with the luteinizing hormone-releasing hormone antagonist compound, cetrorelix.
The first study of this phase III program will assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in benign prostatic hyperplasia (BPH) symptoms.
“Cetrorelix has shown promising and compelling results in our prior extensive phase II program, and we are now very excited about the possibility of bringing to market a safe and novel treatment for the millions of men suffering from BPH,” said Dr Jurgen Engel, executive vice president, Global R&D at Aeterna Zentaris.
“Assuming conclusive results for this phase III program, we would expect to file an NDA by mid-2009.”
Aeterna Zentaris said it is confident that cetrorelix has the potential to successfully penetrate a $4 billion plus market such as BPH.