VIIBRYD Product Monograph

Question 1

What is VIIBRYD indicated for and why is it different from other SSRIs?

Answer 1

MDD in adults. First SSRI and 5-HT (1a) a partial agonist

Question 2

What is the VIIBRYDs drug class?

Answer 2

SSRI and 5HT (1a)

Question 3

How is it dosed?

Answer 3

1-7 10mg (for 7 days)
8-14 20mg (for 7 days)
15+ 40mg

Question 4

What are the 7 points for the Warning and Precautions? SSSAADH

Answer 4

Suicidality
Serotonin syndrome
Seizures
Abnormal bleeding
Activation of Mania/Hypomania
Discontinuation of Treatment with V
Hyponatremia (low sodium in blood)

Question 5

In studies, Most common adverse events >= 5% and at least 2x rate of placebo in the studies were and %? (Do Not Inject VIIBRYD)

Answer 5

Diarrhea (28%) (only 8 days)
Nausea (23%) (only 5 days)
Insomnia (6%)
Vomiting (5%)
DNI were considered mild to moderate

Question 6

No single adverse event reaction that led to discontinuation of treatment __% VIIBRYD in the studies?

Answer 6

> 1%

Question 7

The overall rate of discontinuation for both studies due to adverse events was ___ for VIIBRYD and ___ for placebo

Answer 7

7. 1% in VIIBRYD

3. 2% in Placebo

Question 8

No more than __ of patients reported any one sexual side effect, such as decreased libido, abnormal orgasm, delayed ejac, erectile dysfxn, or sexual dystfxn

Answer 8

5%

Question 9

The Safety of V was evaluated on ____ ages __-__ diagnosed with ____.

Answer 9

2177
18-70 yrs old
MDD

Question 10

The LS mean difference in MADRS for patients using Viibryd vs Placebo was __ (Rickels) and __ (Khan)

Answer 10

-3.2 (Rickels)
-2.5 (Khan)
(negative 2 being considered statistically significant in the eyes of the studies)

Question 11

VIIBRYD potently and selectively inhibits _____ _____ and binds selectively with high affinity to ____ __________

Answer 11

reuptake of serotonin

5-HT (1a) receptor partial agonist

Question 12

ABSORPTION: Taken with food, the concentration peak at a median is ____ and terminal half life is ___ hours

Answer 12

4-5 hours t-max

25 hours

Question 13

Strong inhibitors of CYP3A4 (ketoconazole) can ________ the metabolism of V and ______ exposure.

Answer 13

reduce

increase

Question 14

VIIBRYD is extensively metabolized where?

Answer 14

in the liver, with only 1% recovered in the urine and 2% of feces

Question 15

In order to be in the Rickels and Khan studies what were the criteria for each?

Answer 15

• 18-65 (Rickels) and 18-70 (Khan)
• Met DSM-4 criteria for MDD, single or recurrent
• Duration of current epis.was at least 4 weeks, and no more than 2 years
• HAM-D17 score >=22
• HAM-D17 item 1 (depressed mood) score >=2

Question 16

What was the primary efficacy endpoint of both trials?

Answer 16

Mean change in MADRS total score from baseline to the end of treatment. (assessed at Week 1,2,4,6,8)

Question 17

Rickels study showed a __ reduction over MADRS baseline or __% compared to placebo at ___ or ___%

Answer 17

• 12.9; 42%

- 9.6; 31%

Question 18

Khan study showed a __ reduction over MADRES baseline or __% compared to placebo at ___ or ___%

Answer 18

• 13.3; 42%

- 10.8; 34%

Question 19

VIIBRYD had ____ effect on body weight as measured from baseline in the 8 week study. Mean changes in weight were ___kg. In the 52 week study it was __kg.

Answer 19

NO effect
.16 kg in V vs. .18 kg in placebo
1 kg in 52 week study

Question 20

True or False? VIIBRYD has been systematically studied beyond 8 weeks?

Answer 20

FALSE BITCH!!

Question 21

At what week did the Rickels see a LS mean difference from placebo in change from baseline in MADRS total score vs. Khan’s?

Answer 21

Rickels: Week 1, 2, 4, 6, and 8
Khan: Week 6 and 8

Question 22

Explain contraindications of V

Answer 22

MAOI 14 days vice versa methylene blue linazolid

Question 23

Viibryd MOA

Answer 23

First and only SSRI and 5HT 1a partial agonist.

It is thought that this receptor plays a role in MODULATING serotonin induced transmission

Question 24

How many were on the Robinson study and what %stayed on 40mg?

Answer 24

599 and 90% stayed on 40 mg

Question 25

No single adverse reaction led to discontinuation in <= ___% of patients in phase 3 placebo controlled studies

Answer 25

<= 1%

Question 26

Symptoms of MDD: SIGECAPS

Answer 26

``` Sleep Interest (lack of) Guilt Energy Concentration Appetite Psychomotor Suicide ```

Question 27

5 R's

Answer 27

``` Response Remission (partial or full) Relapse Recovery Recurrence ```

Question 28

MADRS 10 core symptoms

Answer 28

Apparent Sadness Reported Sadness Inner Tension Reduced Sleep Reduced appetite Concentration difficulties Lassitude Inability to feel Pessimistic Thoughts Suicidal thoughts

Question 29

Viibryd is treated for:

Answer 29

MDD in adults

Question 30

How do you talk about V in regards weight

Answer 30

No significant effect on weight

Question 31

Robinson, people stayed at 40 mg ___% of the time. | What were the 3 top AE?

Answer 31

90% Diarrhea Nausea Headache

Question 32

How many people were in the Rickels, Khan and Robinson study

Answer 32

410 - 481 - 599

Question 33

What is the primary endpoint?

Answer 33

MADRS total score from baseline at week 8

Question 34

What Preg category

Answer 34

Pregnancy C:

Question 35

No Dose Adjustment for who?

Answer 35

Hep, Renal, Elderly, and Age and Gender

Question 36

What is the absolute bioavailability of V? compared to oral bioavailability

Answer 36

72% compared to 147-160%

Question 37

Seretonin Syndrome includes

Answer 37

``` Triptans Tricyclic antidepressants Tramadol, Tryptophan, Fentanyl Buspirone St. John's Wort MAOI's Intravenous methylene Blue Linozolid Lithium ```

Question 38

Inhibitors of CYP3A4 like KETOCONAZOLE, how much do you dose and why?

Answer 38

20 mg because it can increase vilazadone plasma concentrations by approx. 50%

Question 39

Viibryd main ingredient name is

Answer 39

vilazadone

Question 40

What was the percent of MD-03 and MD-01

Answer 40

53% and 57%