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FDA approves Watson's six-month Trelstar formulation for palliative treatment of advanced prostate cancer
Thursday, March 11 2010 | Comments
What's This?
The Food and Drug Administration approved Watson Pharmaceuticals Inc.'s six-month formulation of Trelstar (triptorelin pamoate) injectable suspension for the palliative treatment of advanced prostate cancer.The approval was based on data from a Phase III study that involved administering 22.5 mg of Trelstar every 24 weeks to patients with advanced prostate cancer. From the second month through the end of the 48-week study, the patients had a mean testosterone serum level of 12.8 ng/dL, which Watson noted was "well below" castration levels associated with androgen-deprivation therapy.
In addition, 97.5 percent of the participants experienced castrate levels of serum testosterone 28 days after the first injection, and more than 98 percent achieved testosterone suppression that was below castration levels at six and 12 months.
Common adverse events included hot flushes, occurring in 71.7 percent of the participants, erectile dysfunction, which 10 percent of the men reported, and testicular atrophy, occurring in 7.5 percent of the patients.
Watson said this formulation of Trelstar is the only six-month, intramuscular gonadotropin-releasing hormone (GnRH) agonist available for the palliative treatment of advanced prostate cancer.
The firm plans to launch the product in May.
Trelstar is already available in a one-month, 3.75 mg formulation and a three-month, 11.25 mg formulation.
The active ingredient in Trelstar, which was developed by Debiopharm Group, is a decapeptide analog of GnRH.
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