The FDA has approved Trelstar 22.5mg (triptorelin pamoate for injectable suspension, from Watson) for the palliative treatment of advanced prostate cancer. Trelstar 22.5mg is a GnRH analogue intended for twice-yearly administration. This approval was based on data from a Phase 3, 12-month study demonstrating that Trelstar 22.5mg produced a mean testosterone serum level of 12.8ng/dL from month 2–12. By day 29, 97.5% of patients achieved castrate level, and >98% of all patients were below castrate level at month six and month 12. Median prostate specific antigen (PSA) was also reduced by 96.4% at the end of the study.

Trelstar 22.5mg is expected to be available in May 2010.

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