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IMPORTANT SAFETY INFORMATION ABOUT VIIBRYD Prescribing Information

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Efficacy

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Dosing

Mechanism of Action

Important Safety Information

VIIBRYD® has proven efficacy in adults with MDD¹

Khan et al

Rickels et al

MADRS* mean total score reduction from baseline at week 8^2,3

MADRS* total score by study visit^3,6

VIIBRYD delivered significant improvement vs placebo in MADRS* total score in two 8-week,
randomized and controlled studies (P<0.01)^3,5

MADRS* mean total score reduction from baseline at week 8^2,3

VIIBRYD
(n=231)

Placebo
(n=232)

LS^† MEAN CHANGE FROM BASELINE

-2

-4

-6

-8

-10

-12

-14

-16

42% change from baseline
vs 34%
for placebo^2,3

^‡P=0.009 vs placebo

Baseline values: 31.9 for VIIBRYD and 32.0 for placebo

Randomized, double-blind, placebo-controlled, multicenter, 8-week study to determine the efficacy and safety of VIIBRYD in adults aged 18 to 70 years who were diagnosed with MDD. Patients were randomized to receive VIIBRYD (n=231) or placebo (n=232). Last observation carried forward (LOCF) analysis shown.^1,3

The primary efficacy endpoint was the change in MADRS* total score from baseline to week 8 (ITT population).

The LS^† mean difference (95% confidence interval) from placebo in change from baseline in MADRS* total score was -2.5 (-4.4, -0.6).

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.^1,3

*Montgomery-Asberg Depression Rating Scale.
†Least-squares.

Patients taking VIIBRYD experienced greater symptom improvement than those taking placebo

At week 8, LS^† mean difference from placebo in change from baseline in MADRS* total score was -2.5

Khan et al

Rickels et al

MADRS* mean total score reduction from baseline at week 8^2,3

MADRS* total score by study visit^3,6

VIIBRYD demonstrated significant improvement in symptoms of depression vs placebo
at week 8¹

MADRS* total score by study visit^3,6

TREATMENT WEEK

LS^† MEAN CHANGE FROM BASELINE

-2

-4

-6

-8

-10

-12

-14

-16

VIIBRYD (n=231)
Placebo (n=232)

^‡P ≤0.05 vs placebo ^§P ≤0.01 vs placebo

^‡

^§

10
mg/d

20
mg/d

40
mg/d

Randomized, double-blind, placebo-controlled, multicenter, 8-week study to determine the efficacy and safety of VIIBRYD in adults aged 18 to 70 years who were diagnosed with MDD. Patients were randomized to receive VIIBRYD (n=231) or placebo (n=232). Mixed-effects model repeated-measure (MMRM) analysis shown. ^1,3

The primary efficacy endpoint was the change in MADRS* total score from baseline to week 8 (ITT population). The LS^† mean difference (95% confidence interval) from placebo in change from baseline in MADRS* total score was -2.5 (-4.4, -0.6).

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.^1,6

*Montgomery-Asberg Depression Rating Scale.
†Least-squares.

Whether the statistically significant differences observed at time points earlier than 8 weeks represent clinically relevant
treatment effects is unknown

Khan et al

Rickels et al

MADRS* mean total score reduction from baseline at week 8^2,5

MADRS* total score by study visit^5,6

VIIBRYD delivered significant improvement vs placebo in MADRS* total score in two 8-week,
randomized and controlled studies (P<0.01)^3,5

MADRS* mean total score reduction from baseline at week 8^2,5

VIIBRYD
(n=198)

Placebo
(n=199)

LS^† MEAN CHANGE FROM BASELINE

-2

-4

-6

-8

-10

-12

-14

-16

42% change from baseline
vs 31%
for placebo^2,5

^‡P=0.001 vs placebo

Baseline values: 30.8 for VIIBRYD and 30.7 for placebo

Randomized, double-blind, placebo-controlled, multicenter, 8-week study to determine the efficacy and safety of VIIBRYD in adults aged 18 to 65 years who were diagnosed with MDD. Patients were randomized to receive VIIBRYD (n=198) or placebo (n=199). Last observation carried forward (LOCF) analysis shown.^1,5

The primary efficacy endpoint was the change in MADRS* total score from baseline to week 8 (ITT population).

The LS^† mean difference (95% confidence interval) from placebo in change from baseline in MADRS* total score was -3.2 (-5.2, -1.3).

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.^1,5

*Montgomery-Asberg Depression Rating Scale.
†Least-squares.

Patients taking VIIBRYD experienced greater symptom improvement than those taking placebo

At week 8, LS† mean difference from placebo in change from baseline in MADRS* total score was -3.2

Khan et al

Rickels et al

MADRS* mean total score reduction from baseline at week 8^2,5

MADRS* total score by study visit^5,6

VIIBRYD demonstrated significant improvement in symptoms of depression vs placebo
at week 8¹

MADRS* total score by study visit^5,6

TREATMENT WEEK

LS^† MEAN CHANGE FROM BASELINE

-2

-4

-6

-8

-10

-12

-14

-16

VIIBRYD (n=198)
Placebo (n=199)

^‡P ≤0.001 vs placebo ^§P <0.05 vs placebo

^‡

^§

^‡

10
mg/d

20
mg/d

40
mg/d

Randomized, double-blind, placebo-controlled, multicenter, 8-week study to determine the efficacy and safety of VIIBRYD in adults aged 18 to 65 years who were diagnosed with MDD. Patients were randomized to receive VIIBRYD (n=198) or placebo (n=199). Mixed effects model repeated-measure (MMRM) analysis shown.^1,5

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.^1,5

*Montgomery-Asberg Depression Rating Scale.
†Least-squares.

The efficacy of VIIBRYD has not been systematically evaluated beyond 8 weeks. It is generally agreed that acute
episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Patients
should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment
Whether the statistically significant differences observed at time points earlier than 8 weeks represent clinically
relevant treatment effects is unknown.

MADRS* rates these 10 core symptoms of depression⁴

Apparent Sadness	Reported Sadness	Inner Tension
Reduced Sleep	Reduced Appetite	Concentration Difficulties
Lassitude	Inability to Feel	Pessimistic Thoughts
Suicidal Thoughts

VIIBRYD delivered significant improvement vs placebo in MADRS* total score in two 8-week, randomized and
controlled studies (P<0.01)^3,5

Khan et al

MADRS* mean total score reduction from baseline at week 8^2,3

VIIBRYD
(n=231)

Placebo
(n=232)

LS^† MEAN CHANGE FROM BASELINE

-2

-4

-6

-8

-10

-12

-14

-16

42% change from baseline
vs 34%
for placebo^2,3

^‡P=0.009 vs placebo

Baseline values: 31.9 for VIIBRYD and 32.0 for placebo

The primary efficacy endpoint was the change in MADRS* total score from baseline to week 8 (ITT population).

The LS^† mean difference (95% confidence interval) from placebo in change from baseline in MADRS* total score was -2.5 (-4.4, -0.6).

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.^1,3

*Montgomery-Asberg Depression Rating Scale.
†Least-squares.

Patients taking VIIBRYD experienced greater symptom improvement than those taking placebo

At week 8, LS^† mean difference from placebo in change from baseline in MADRS* total score was -2.5

MADRS* rates these 10 core symptoms of depression⁴

Apparent Sadness	Reported Sadness	Inner Tension
Reduced Sleep	Reduced Appetite	Concentration Difficulties
Lassitude	Inability to Feel	Pessimistic Thoughts
Suicidal Thoughts

VIIBRYD demonstrated significant improvement in symptoms of depression vs placebo at week 8¹

Khan et al

MADRS* total score by study visit^3,6

TREATMENT WEEK

LS^† MEAN CHANGE FROM BASELINE

-2

-4

-6

-8

-10

-12

-14

-16

VIIBRYD (n=231)
Placebo (n=232)

^‡P ≤0.05 vs placebo ^§P ≤0.01 vs placebo

^‡

^§

10
mg/d

20
mg/d

40
mg/d

Randomized, double-blind, placebo-controlled, multicenter, 8-week study to determine the efficacy and safety of VIIBRYD in adults aged 18 to 70 years who were diagnosed with MDD. Patients were randomized to receive VIIBRYD (n=231) or placebo (n=232). Mixed-effects model repeated-measure (MMRM) analysis shown. ^1,3

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.^1,6

*Montgomery-Asberg Depression Rating Scale.
†Least-squares.

Whether the statistically significant differences observed at earlier time points represent clinically relevant treatment
effects is unknown

VIIBRYD delivered significant improvement vs placebo in MADRS* total score in two 8-week, randomized and
controlled studies (P<0.01)^3,5

Rickels et al

MADRS* mean total score reduction from baseline at week 8^2,5

VIIBRYD
(n=198)

Placebo
(n=199)

LS^† MEAN CHANGE FROM BASELINE

-2

-4

-6

-8

-10

-12

-14

-16

42% change from baseline
vs 31%
for placebo^2,5

^‡P=0.001 vs placebo

Baseline values: 30.8 for VIIBRYD and 30.7 for placebo

The primary efficacy endpoint was the change in MADRS* total score from baseline to week 8 (ITT population).

The LS^† mean difference (95% confidence interval) from placebo in change from baseline in MADRS* total score was -3.2 (-5.2, -1.3).

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.^1,5

*Montgomery-Asberg Depression Rating Scale.
†Least-squares.

Patients taking VIIBRYD experienced greater symptom improvement than those taking placebo

At week 8, LS^† mean difference from placebo in change from baseline in MADRS* total score was -3.2

VIIBRYD demonstrated significant improvement in symptoms of depression vs placebo at week 8¹

Rickels et al

MADRS* total score by study visit^5,6

TREATMENT WEEK

LS^† MEAN CHANGE FROM BASELINE

-2

-4

-6

-8

-10

-12

-14

-16

VIIBRYD (n=198)
Placebo (n=199)

^‡P ≤0.001 vs placebo ^§P <0.05 vs placebo

^‡

^§

^‡

10
mg/d

20
mg/d

40
mg/d

Randomized, double-blind, placebo-controlled, multicenter, 8-week study to determine the efficacy and safety of VIIBRYD in adults aged 18 to 65 years who were diagnosed with MDD. Patients were randomized to receive VIIBRYD (n=198) or placebo (n=199). Mixed effects model repeated-measure (MMRM) analysis shown.^1,5

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.^1,5

*Montgomery-Asberg Depression Rating Scale.
†Least-squares.

The efficacy of VIIBRYD has not been systematically evaluated beyond 8 weeks. It is generally agreed that acute episodes of major depressive
disorder require several months or longer of sustained pharmacologic therapy. Patients should be reassessed periodically to determine the
need for maintenance treatment and the appropriate dose for treatment
Whether the statistically significant differences observed at time points earlier than 8 weeks represent clinically
relevant treatment effects is unknown.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of VIIBRYD or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. VIIBRYD is not approved for use in pediatric patients.

Contraindications

Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with VIIBRYD or within 14 days of stopping treatment with VIIBRYD. Do not use VIIBRYD within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start VIIBRYD in a patient who is being treated with linezolid or intravenous methylene blue.

Warnings and Precautions

All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients daily. Prescriptions for VIIBRYD should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including VIIBRYD, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue VIIBRYD and initiate supportive treatment. If concomitant use of VIIBRYD with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. Patients should be monitored for the emergence of serotonin syndrome.
Like other antidepressants, VIIBRYD should be prescribed with caution in patients with a seizure disorder.
The use of drugs that interfere with serotonin reuptake, including VIIBRYD, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of VIIBRYD and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation or bleeding.
Symptoms of mania/hypomania were noted in 0.1% of patients treated with VIIBRYD in clinical studies. As with all antidepressants, VIIBRYD should be used cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.
Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. VIIBRYD is not approved for use in treating bipolar depression.
Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.
Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking VIIBRYD. Although no cases of hyponatremia resulting from VIIBRYD treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. Discontinuation of VIIBRYD in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

Adverse Reactions

The most commonly observed adverse reactions in MDD patients treated with VIIBRYD in placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were: diarrhea (28% vs 9%), nausea (23% vs 5%), insomnia (6% vs 2%), and vomiting (5% vs 1%).

Please also see full Prescribing Information

References:

1. Viibryd (vilazodone HCl) [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc.; 2012. 2. Data on file. Forest Laboratories, Inc. 3. Khan A, Cutler AJ, Kajdasz DK, et al. A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder. J Clin Psychiatry. 2011;72:441-447. 4. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382-389. 5. Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70:326-333. 6. Thase ME, Athanasiou MC, Kajdasz DK, Gallipoli S, Whalen H, Reed CR. The efficacy profile of vilazodone, a novel, dual-acting serotonergic antidepressant in the treatment of major depressive disorder. Poster presented at: the 23rd Annual U.S. Psychiatric and Mental Health Congress; November 18-21, 2010; Orlando, FL.

VIIBRYD® has proven efficacy in adults with MDD1

VIIBRYD® has proven efficacy in adults with MDD¹