Prescription Drug Information: Desvenlafaxine (Page 3 of 10)

6.1 Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Patient Exposure

Desvenlafaxine extended-release tablets were evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of desvenlafaxine extended-release tablets; 2,116 were exposed to desvenlafaxine extended-release tablets for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure.

Adverse Reactions Reported as Reasons for Discontinuation of Treatment

In the pre-marketing pooled 8-week placebo-controlled studies in patients with MDD, 1,834 patients were exposed to desvenlafaxine extended-release tablets (50 mg to 400 mg). Of the 1,834 patients, 12% discontinued treatment due to an adverse reaction, compared with 3% of the 1,116 placebo-treated patients. At the recommended dose of 50 mg, the discontinuation rate due to an adverse reaction for desvenlafaxine extended-release tablets (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of desvenlafaxine extended-release tablets the discontinuation rate due to an adverse reaction was 8.7%.

The most common adverse reactions leading to discontinuation in at least 2% and at a rate greater than placebo of the desvenlafaxine extended-release tablets treated patients in the short-term studies, up to 8 weeks, were: nausea (4%); dizziness, headache and vomiting (2% each). In a longer-term study, up to 9 months, the most common was vomiting (2%).

Common Adverse Reactions in Placebo-Controlled MDD Studies

The most commonly observed adverse reactions in desvenlafaxine extended-release tablets treated MDD patients in pre-marketing pooled 8-week, placebo-controlled, fixed-dose studies (incidence ≥ 5% and at least twice the rate of placebo in the 50 mg or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.

Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of desvenlafaxine extended-release tablets treated MDD patients and twice the rate of placebo at any dose in the pre-marketing pooled 8-week, placebo-controlled, fixed-dose clinical studies.

Table 2: Common Adverse Reactions (≥ 2% in any Fixed-Dose Group and Twice the Rate of Placebo) in Pre-Marketing Pooled MDD 8-Week Placebo-Controlled Studies

Percentage of Patients Reporting Reaction

Desvenlafaxine Extended-Release Tablets

System Organ Class

Preferred Term

Placebo

(n = 636)

50 mg

(n = 317)

100 mg

(n = 424)

200 mg

(n = 307)

400 mg

(n = 317)

Cardiac disorders

Blood pressure increased

1

1

1

2

2

Gastrointestinal disorders

Nausea

10

22

26

36

41

Dry mouth

9

11

17

21

25

Constipation

4

9

9

10

14

Vomiting

3

3

4

6

9

General disorders and administration site conditions

Fatigue

4

7

7

10

11

Chills

1

1

< 1

3

4

Feeling jittery

1

1

2

3

3

Metabolism and nutrition disorders

Decreased appetite

2

5

8

10

10

Nervous system disorders

Dizziness

5

13

10

15

16

Somnolence

4

4

9

12

12

Tremor

2

2

3

9

9

Disturbance in attention

< 1

< 1

1

2

1

Psychiatric disorders

Insomnia

6

9

12

14

15

Anxiety

2

3

5

4

4

Nervousness

1

< 1

1

2

2

Abnormal dreams

1

2

3

2

4

Renal and urinary disorders

Urinary hesitation

0

< 1

1

2

2

Respiratory, thoracic and mediastinal disorders

Yawning

< 1

1

1

4

3

Skin and subcutaneous tissue disorders

Hyperhidrosis

4

10

11

18

21

Special senses

Vision blurred

1

3

4

4

4

Mydriasis

< 1

2

2

6

6

Vertigo

1

2

1

5

3

Tinnitus

1

2

1

1

2

Dysgeusia

1

1

1

1

2

Vascular disorders

Hot flush

< 1

1

1

2

2

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