LABOPHARM RECEIVES HEALTH CANADA APPROVAL FOR OLEPTRO(TM): A NEW ONCE-DAILY ANTIDEPRESSANT FOR THE TREATMENT OF MAJOR DEPRESSIV

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Celgene verffentlicht aktuelle Informationen ber Zulassungsverfahren

LABOPHARM RECEIVES HEALTH CANADA APPROVAL FOR OLEPTRO(TM): A NEW ONCE-DAILY ANTIDEPRESSANT FOR THE TREATMENT OF MAJOR DEPRESSIV

//health-fitness.news-articles.net/content/2011/ .. essant-for-the-treatment-of-major-depressiv.html

Published in Health and Fitness on Thursday, January 20th 2011 at 6:55 GMT by Market Wire
^{🞛 This publication is a summary or evaluation of another publication}

 - The change from baseline in mean HAMD-17 total score was seen as early as week 1 and throughout the 8-week study vs. placebo (p less than 0.05) (full antidepressant effect may take 4 to 6 weeks); - No notable weight gain and a low incidence of sexual dysfunction; - The most common adverse events (incidence greater than or equal to 5% and twice that of placebo) were somnolence/sedation, dizziness, constipation and blurred vision; - In the OLEPTRO(TM) group, only 4 percent of patients discontinued treatment due to somnolence or sedation; - Statistical significance was achieved for the majority of prespecified secondary endpoints.

 --------------------------------- (1) Bostwick, J.M., A Generalist's Guide to Treating Patients with Depression with an Emphasis on Using Side Effects to Tailor Antidepressant Therapy. Mayo Clin Proc. 2010;85(6):538-550 (2) Lin E.H. et al. Medcare.1995;33:67-74