French pharmaceutical firm Ipsen has reported positive results from the Phase III trial of triptorelin pamoate 11.25mg (Decapeptyl 3 months) administered subcutaneously in men with locally advanced or metastatic prostate cancer.
The trial’s primary objective was to evaluate the efficacy and safety profile of the sustained-release triptorelin pamoate 11.25mg in these patients.
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The objective was met with castration levels of testosterone achieved in 97.6% of men at week four and castration maintained in 96.6%of these men at week 26.
The company said mean testosterone levels decreased to 18.4ng/dl and 10.2ng/dl at week four and week eight, respectively, and remained in this range until the end of the trial.
The trial showed the median prostate specific antigen (PSA) levels were reduced by 64.2% and 96% at week four and week 26, respectively, while PSA levels remained within the normal range of 0-4ng/ml from week eight until the end of the trial.
The efficacy results and safety profile of triptorelin pamoate 11.25mg administered by the subcutaneous route are consistent with the known efficacy and safety profile of triptorelin administered by the intramuscular route.
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By GlobalDataBased on these results, the company has applied for the addition of the subcutaneous route, alongside the intramuscular route, to the label of triptorelin pamoate 11.25mg.
Ipsen executive vice-president research and development and chief scientific officer Claude Bertrand said: "These results provide further evidence to the efficacy and safety of decapeptyl in the treatment of patients with prostate cancer.
"The subcutaneous route widens the options for the administration of Decapeptyl and may be offered to patients for whom intramuscular administration is not recommended.
"Ipsen is pleased to reaffirm its positioning as a patient-centric organisation."
In the multicentre, open-label, single-arm trial of triptorelin pamoate 11.25mg given by the subcutaneous route twice, patients from 14 centres were monitored for 26 weeks between October 2012 and October 2013.
