Based on these results, the company intends to apply for the addition of the subcutaneous route, alongside the intramuscular route, to the label of triptorelin pamoate 11.25mg.
The single arm, open label Phase III trial evaluated the efficacy, safety and local tolerability of a 3-month triptorelin pamoate (11.25mg) given subcutaneously to patients.
The co-primary end points of the trial were the proportion of patients castrated at Day 29, and the proportion of patients with castration maintained at Day 183.
According to company, castration is defined by testosterone levels of< 50 ng/dL.
Around 120 patients have participated in the trial, which was conducted in five European countries including Latvia, Bulgaria, Romania, Poland and France.
Ipsen executive vice-president of Research & Development and chief scientific officer Claude Bertrand said the efficacy and safety of triptorelin pamoate 11.25mg in the treatment of patients with prostate cancer is well-established.
"The availability of an efficacious and safe subcutaneous formulation offers a more convenient and suitable way of administrating triptorelin pamoate to patients on oral anticoagulants or cachectic patients for whom intramuscular administration is not recommended," Bertrand said.
"Through its willingness to offer a wider and more adapted product range, Ipsen reaffirms its positioning as a patient-centric organization."