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