Ipsen initiates Ph III trial of Decapeptyl SR

French drugmaker Ipsen has initiated a Phase III trial of a four-month sustained-release formulation of Decapeptyl (triptorelin) based on the firm's proprietary drug delivery technology. This development is part of the life-cycle management strategy for the product, an injectible peptide analog of gonadotrophin-releasing hormone, which was initially developed and continues to be mainly used in the treatment of advanced metastatic prostate cancer.

The Paris-headquartered company noted that Decapeptyl is also indicated in the treatment of uterine fibroids (a benign tumor of muscle uterine tissues), endometriosis (proliferation of endometrial tissue, the mucous membrane that lines the uterine wall outside the reproductive tract), prior to surgery or when surgery is not appropriate, as well as early-onset puberty and in vitro fertilization.

The agent is available in monthly or quarterly sustained-release formulations, as well as a daily formulation, and it has marketing authorizations in over 60 countries, including 25 in Europe. In 2005, 67.1% of Decapeptyl sales of a total amount of 210.6 million euros ($276.1 million) derived from the major western European countries. For the first nine months of 2006, income from the drug reached 168.4 million euros, up 5.7% on the first nine months of the previous year.