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» Home » Articles » FDA approved the drug Trelstar (triptorelin)

FDA approved the drug Trelstar (triptorelin)

Date: Wednesday 17 March, 2010

US Food and Drug Administration USA (FDA) approved the drug Trelstar (triptorelin) 22.5 mg for intramuscular administration in the first 6-month course of palliative treatment of advanced prostate cancer.

Trelstar (triptorelin pamoat) in the form suspension for injection is an agonist of gonadotropin-releasing hormone with proven efficacy and favorable safety profile for the palliative treatment of prostate cancer. TRELSTAR Depot and TRELSTAR LA may serve as alternative treatment for prostate cancer when orchiectomy or estrogen application is not acceptable for the patients.
Previously, Trelstar was only available in forms designed for 1 month (3.75 mg) and for 3 months (11.25 mg) treatment. The new version of long-acting formulation allows patients to improve quality of life for a long period of time. The drug possesses a good safety profile and is well tolerated in most patients.
Trelstar is indicated with a delivery system MIXJECT, which uses a particularly thin needle, resulting in reduced risk of pain at the injection site. The procedure of injection became easy and virtually painless.

FDA decision is based on a 12-month clinical study of 3-phases, confirmed the high efficiency and rare for this class drug safety.

 



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