New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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