FDA Approves 6-Month Formulation of Triptorelin Pamoate for Advanced Prostate Cancer
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FDA Approves 6-Month Formulation of Triptorelin Pamoate for Advanced Prostate Cancer

NEW YORK -- March 11, 2010 -- The US Food and Drug Administration (FDA) has approved a new longer-acting, 6-month formulation of triptorelin pamoate for injectable suspension (Trelstar) for the palliative treatment of advanced prostate cancer.

The approval is based on a 48-week, phase 3 study evaluating the efficacy, pharmacokinetics, and safety of triptorelin pamoate 22.5 mg administered every 6 months (24 weeks) in patients with advanced prostate cancer.

Over the study, triptorelin pamoate produced a mean testosterone serum level of 12.8 ng/dL from month 2 through month 12, well below castration levels associated with androgen deprivation therapy.

By day 29, 97.5% of the clinical trial patients achieved castrate level, and more than 98% of all patients were below castrate level at month 6 and month 12.

Median prostate specific antigen (PSA) was also reduced by 96.4% at the end of the study.

The most commonly reported adverse events included hot flushes (71.7%), erectile dysfunction (10.0%), and testicular atrophy (7.5%).

SOURCE: Watson Pharmaceuticals, Inc.

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