Ferring Pharmaceuticals Announces Immediate Availability of Degarelix for the Treatment of Advanced Prost...( N ...),Health

Date:3/4/2009

N Patients with % (95% CI) treatment response Degarelix 207 202 97.2 240/80 mg Leuprolide 7.5 mg 201 194 96.4

Suppression of testosterone levels to less than or equal to 50 ng/dL occurred significantly faster in patients receiving degarelix than in those receiving leuprolide. At Day 3 of treatment, the degarelix group achieved a 90 percent decrease in median testosterone levels, compared to the leuprolide group which experienced a 65 percent increase in median testosterone levels.

The most commonly observed adverse reactions during degarelix therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). Ninety-nine percent of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in two percent or less of patients receiving degarelix.

Degarelix is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. Degarelix is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.'/>"/>

SOURCE Ferring Pharmaceuticals Copyright©2009 PR Newswire. All rights reserved

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