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news.Canadian biopharmaceutical company Aeterna Zentaris plans to submit an investigational new drug application to the FDA to begin a phase III trial of Cetrorelix, its treatment for benign prostatic hyperplasia.
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The Quebec-based company announced that during a recent end of phase II meeting, the FDA reviewed the safety and efficacy data from an extensive phase II program with Cetrorelix, its lead product candidate for the treatment of benign prostatic hyperplasia (BPH).
Accordingly, the company plans to submit an (IND) application to the FDA within the next few months for the initiation of a phase III program for Cetrorelix in BPH.
BPH, which affects more than 50% of men over 60, is characterized by an abnormal benign growth of the prostatic tissues caused by testosterone. Symptoms linked to BPH include pain while urinating and frequent urges to urinate during the night and sometimes, kidney problems. In some cases, if left untreated, BPH may develop into prostate cancer.
“Cetrorelix has shown promising and compelling results in our extensive phase II program, and we now look forward to bringing it to its final development stage,” said Dr Jurgen Engel, COO at Aeterna Zentaris.