Ferring Pharmaceuticals has announced that new data from a Phase III study has demonstrated that the investigational GnRH blocker, degarelix, produced a significant reduction in levels of testosterone within three days in more than 96% of study patients.
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The new data also showed that degarelix provided an extremely fast effect on testosterone levels, close to the immediate effect achieved with surgery (orchidectomy), the company said.
The Phase III study compared monthly administration of degarelix with monthly LHRH agonist leuprorelin’s 7.5mg in a 12-month randomized, open-label, parallel-group study in prostate cancer (PCa) patients. In comparison to leuprorelin, degarelix suppressed serum testosterone and Prostate Specific Antigen (PSA) significantly faster. In addition, degarelix was able to sustain these low levels during the entire 12-month study.
By day three of the study, testosterone levels were suppressed to less than or equal to 0.5ng/mL in 96% of patients in the degarelix arms of the study compared to 0% in the leuprorelin arm. By day 14 100% of patients in the degarelix arms achieved suppression of testosterone levels at less than or equal to 0.5ng/mL compared to 18.2% in the leuprorelin arm.
After 14 days of treatment, PSA levels had declined in the degarelix treated patients by a median of 64%, while patients who were administered leuprorelin saw an 18% decline.
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