AEterna Zentaris has announced that the FDA has reviewed the safety and efficacy data from an extensive Phase II program with cetrorelix, its lead luteinizing hormone-releasing hormone antagonist product candidate, for the treatment of benign prostatic hyperplasia (BPH).
Accordingly, the company plans to submit an investigational new drug application to the FDA within the next few months for the initiation of a Phase III program for cetrorelix in BPH.