New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Vilazodone HCl - Viibryd • The primary outcome of the study was mean change from baseline to week 8 (end of treatment) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score. – Mean change from baseline to week 8 in MADRS total score was 12.9 with vilazodone compared with 9.6 with placebo (P = 0.001). – Vilazodone also resulted in significant reductions in the HAM-D- 17 (10.4 vs 8.6, P = 0.022), – Response, defined as a 50% or greater reduction in total score from baseline to week 8 on the MADRS or HAM-D-17 total scores, or a score of 1 or 2 on the CGI-I, was achieved in 40% to 48% of vilazodone-treated patients compared with 28% to 32% of placebo recipients. – The discontinuation rate in the vilazodone arm was 9.3% compared with 4.9% in the placebo group (primarily diarrhea) Vilazodone HCl - Viibryd WARNINGS AND PRECAUTIONS • Vilazodone labeling includes class cautions regarding clinical worsening and suicide risk (Box Warning), serotonin syndrome, neuroleptic malignant–like syndrome, seizures, abnormal bleeding, activation of mania/hypomania, and hyponatremia • A gradual dosage reduction is recommended to minimize discontinuation symptoms • The vilazodone dose should be reduced to 20 mg when coadministered with strong CYP3A4 inhibitors. • Coadministration of vilazodone with CYP3A4 inducers can result in reduced vilazodone concentrations, and may reduce its effectiveness. Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Vilazodone HCl - Viibryd Table 3. Most Common Adverse Events With Vilazodone Reported in Placebo-Controlled Depression Studies in Patients With MDD Vilazodone 40 mg/day (n = 436) Placebo (n = 433) Diarrhea 28% 9% Nausea 23% 5% Dizziness 9% 5% Dry mouth 8% 5% Insomnia 6% 2% Vomiting 5% 1% Fatigue 4% 3% Abnormal dreams 4% 1% Libido decreased 4% < 1% Somnolence 3% 2% Orgasm abnormal 3% 0% Vilazodone HCl - Viibryd Dosing: • The recommended dosage of vilazodone is 40 mg once daily. Therapy should be initiated with a dosage of 10 mg once daily for 7 days, then 20 mg once daily for an additional 7 days, and then increased to 40 mg once daily. When discontinuing therapy, the dosage should be reduced gradually. • Vilazodone should be taken with food. Administration without food may result in inadequate absorption and reduced effectiveness. • Cost $144.00/30 x 40 mg tabs WAC Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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