informative: Clinical study results
Viibryd efficacy demonstrated through multiple studies in adults with MDD
Significant improvement in MADRS total score vs placebo at
primary endpoint (P≤0.01)


MADRS total scores at baseline: 30.8 for VIIBRYD and 30.7 for placebo
from baseline vs 31% for placebo1
LS mean difference (95% confidence interval) from placebo in change from baseline in MADRS total score was -3.2 (-5.2, -1.3) at week 8. Last observation carried forward (LOCF) analysis shown.2
§P=0.001 vs placebo.
- Whether the statistically significant differences observed at time points earlier than 8 weeks represent clinically relevant treatment effects in this study is unknown
Randomized, double-blind, placebo-controlled, multicenter study to determine the efficacy and safety of VIIBRYD in adults aged 18-65 years who were diagnosed with MDD. Primary endpoint was the change in MADRS total score from baseline to week 8 in the intent-to-treat (ITT) population (LOCF analysis). Mixed-effects model repeated-measure (MMRM) analysis is shown for change by treatment week.
VIIBRYD treatment was initiated once daily at 10 mg for 7 days, followed by 20 mg for another 7 days, and 40 mg thereafter until the end of week 8. VIIBRYD was administered with food.1,2
*Least squares.
Significant improvement in MADRS total score vs placebo at
primary endpoint (P≤0.01)


MADRS total scores at baseline: 31.9 for VIIBRYD and 32.0 for placebo
from baseline vs 34% for placebo3
LS mean difference (95% confidence interval) from placebo in change from baseline in MADRS total score was -2.5 (-4.4, -0.6) at week 8. LOCF analysis shown.2
‡P=0.009 vs placebo.
- Whether the statistically significant differences observed at time points earlier than 8 weeks represent clinically relevant treatment effects in this study is unknown
Randomized, double-blind, placebo-controlled, multicenter study to determine the efficacy and safety of VIIBRYD in adults aged 18-70 years who were diagnosed with MDD. Primary endpoint was the change in MADRS total score from baseline to week 8 in the intent-to-treat (ITT) population (LOCF analysis). Mixed-effects model repeated-measure (MMRM) analysis is shown for change by treatment week.
VIIBRYD treatment was initiated once daily at 10 mg for 7 days, followed by 20 mg for another 7 days, and 40 mg thereafter until the end of week 8. VIIBRYD was administered with food.2,3
Significant improvement in MADRS total score vs placebo at
primary endpoint (P≤0.01)


MADRS total scores at baseline: 30.7 for VIIBRYD and 30.9 for placebo
from baseline vs 36% for placebo2
LS mean difference (95% confidence interval) from placebo in change from baseline in MADRS total total score was -5.1 (-6.9, -3.3) at week 8. MMRM analysis shown.2
‡P=0.00001 vs placebo.
- Whether the statistically significant differences observed at time points earlier than 8 weeks represent clinically relevant treatment effects in this study is unknown
Randomized, double-blind, placebo-controlled, multicenter studies to determine the efficacy and safety of VIIBRYD in adults aged 18-70 years who were diagnosed with MDD. Primary endpoint was the change in MADRS total score from baseline to week 8 in the ITT population (MMRM analysis). MMRM analysis is shown for change by treatment week.
VIIBRYD treatment was initiated once daily at 10 mg for 7 days, followed by 20 mg for another 7 days, and 40 mg thereafter until the end of week 8. VIIBRYD was administered with food.4
Significant improvement in MADRS total score vs placebo at
primary endpoint (P≤0.01)


Baseline values: 31.3 for VIIBRYD 20 mg, 31.2 for VIIBRYD 40 mg, and 31.4 for placebo
55% IMPROVEMENT from baseline vs 47% for placebo2
56% IMPROVEMENT from baseline vs 47% for placebo2
LS mean difference (95% CI) from placebo in change from baseline in MADRS total score was -2.6 (-4.3, -0.8) for the 20 mg dose and -2.8 (-4.6, -1.1) for the 40 mg dose at week 10. MMRM analysis shown.2
¶P<0.01 vs placebo.
- Whether the statistically significant differences observed at time points earlier than 10 weeks represent clinically relevant treatment effects in this study is unknown
Randomized, double-blind, placebo-controlled, multicenter study to determine the efficacy and safety of VIIBRYD in adults aged 18-70 years who were diagnosed with MDD. Primary endpoint was the change in MADRS total score from baseline to week 10 in the ITT population. MMRM analysis is shown for change by treatment week. All patients received 10 mg/day for the first 7 days and then 20 mg/day on days 8-14. Patients in the 20 mg/day group remained on this dose until week 10. Patients in the 40 mg/day group received this dose from day 15 onward until week 10. VIIBRYD was administered with food.2,5
*Statistical significance shown is for VIIBRYD 20 mg/day vs placebo and VIIBRYD 40 mg/day vs placebo. This trial was not powered to demonstrate statistical significance between VIIBRYD 20 mg/day and VIIBRYD 40 mg/day.5
Viibryd should be taken with food2
- Taking Viibryd on an empty stomach can reduce plasma concentrations (AUC) by approximately 50% and may diminish effectiveness
Rickels Pivotal Study
Viibryd should be taken with food2
- Taking Viibryd on an empty stomach can reduce plasma concentrations (AUC) by approximately 50% and may diminish effectiveness
Khan Pivotal Study
Croft Postmarketing Study
Mathews Postmarketing Study
References
- Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR. J Clin Psychiatry. 2009;70(3):326-333.
- VIIBRYD (vilazodone HCl) [package insert]. Madison, NJ: Allergan USA, Inc.
- Khan A, Cutler AJ, Kajdasz DK, et al. J Clin Psychiatry. 2011;72:441-447.
- Croft HA, Pomara N, Gommoll C, Chen D, Nunez R, Mathews M. J Clin Psychiatry. 2014 Nov;75(11):e1291-1298.
- Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Int Clin Psychopharmacol. 2015;30(2):67-74.