Azilect (Page 3 of 8)

6.1 Clinical Trials 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 the incidence of adverse reactions in the clinical trials of another drug and may not reflect the rates of adverse reactions observed in practice.

During the clinical development of AZILECT, Parkinson’s disease patients received AZILECT as initial monotherapy (Study 1) and as adjunct therapy (Study 2, Study 3, Study 4). As the populations in these studies differ, not only in the adjunct use of dopamine agonists or levodopa during AZILECT treatment, but also in the severity and duration of their disease, the adverse reactions are presented separately for each study.

Monotherapy Use of AZILECT

In Study 1, approximately 5% of the 149 patients treated with AZILECT discontinued treatment due to adverse reactions compared to 2% of the 151 patients who received placebo.

The only adverse reaction that led to the discontinuation of more than one patient was hallucinations.

The most commonly observed adverse reactions in Study 1 (incidence in AZILECT-treated patients 3% or greater than the incidence in placebo-treated patients) included flu syndrome, arthralgia, depression, and dyspepsia. Table 1 lists adverse reactions that occurred in 2% or greater of patients receiving AZILECT as monotherapy and were numerically more frequent than in the placebo group in Study 1.

Table 1: Adverse Reactions* in Study 1

AZILECT 1 mg (N=149)

Placebo (N=151)

% of Patients

% of Patients

Headache

14

12

Arthralgia

7

4

Dyspepsia

7

4

Depression

5

2

Fall

5

3

Flu syndrome

5

1

Conjunctivitis

3

1

Fever

3

1

Gastroenteritis

3

1

Rhinitis

3

1

Arthritis

2

1

Ecchymosis

2

0

Malaise

2

0

Neck Pain

2

0

Paresthesia

2

1

Vertigo

2

1

*Incidence 2% or greater in AZILECT 1 mg group and numerically more frequent than in placebo group

There were no significant differences in the safety profile based on age or gender.

Adjunct Use of AZILECT

AZILECT was studied as an adjunct therapy without levodopa (Study 2), or as an adjunct therapy to levodopa, with some patients also taking dopamine agonists, COMT inhibitors, anticholinergics, or amantadine (Study 3 and Study 4).

In Study 2, approximately 8% of the 162 patients treated with AZILECT discontinued treatment due to adverse reactions compared to 4% of the 164 patients who received placebo.

Adverse reactions that led to the discontinuation of more than one patient were nausea and dizziness.

The most commonly observed adverse reactions in Study 2 (incidence in AZILECT-treated patients 3% or greater than incidence in placebo-treated patients) included peripheral edema, fall, arthralgia, cough, and insomnia. Table 2 lists adverse reactions that occurred in 2% or greater in patients receiving AZILECT as adjunct therapy without levodopa and numerically more frequent than in the placebo group in Study 2.

Table 2: Adverse Reactions* in Study 2

AZILECT 1 mg (N=162)

Placebo

(N=164)

% of Patients

% of Patients

Dizziness

7

6

Peripheral edema

7

4

Headache

6

4

Nausea

6

4

Fall

6

1

Arthralgia

5

2

Back pain

4

3

Cough

4

1

Insomnia

4

1

Upper respiratory tract infection

4

2

Orthostatic hypotension

3

1

*Incidence 2% or greater in AZILECT 1 mg group and numerically more frequent than in placebo group

There were no significant differences in the safety profile based on age or gender.

In Study 3, adverse event reporting was considered more reliable than Study 4; therefore, only the adverse event data from Study 3 are presented below.

In Study 3, approximately 9% of the 164 patients treated with AZILECT 0.5 mg/day and 7% of the 149 patients treated with AZILECT 1 mg/day discontinued treatment due to adverse reactions, compared to 6% of the 159 patients who received placebo. The adverse reactions that led to discontinuation of more than one AZILECT-treated patient were diarrhea, weight loss, hallucination, and rash.

The most commonly observed adverse reactions in Study 3 (incidence in AZILECT-treated patients 3% or greater than the incidence in placebo-treated patients) included dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and tenosynovitis.

Table 3 lists adverse reactions that occurred in 2% or greater of patients treated with AZILECT 1 mg/day and that were numerically more frequent than the placebo group in Study 3.

Table 3: Adverse Reactions* in Study 3

AZILECT 1 mg

(N=149)

AZILECT 0.5 mg (N=164)

Placebo (N=159)

% of Patients

% of Patients

% of Patients

Dyskinesia

18

18

10

Accidental injury

12

8

5

Nausea

12

10

8

Headache

11

8

10

Fall

11

12

8

Weight loss

9

2

3

Constipation

9

4

5

Postural hypotension

9

6

3

Arthralgia

8

6

4

Vomiting

7

4

1

Dry mouth

6

2

3

Rash

6

3

3

Somnolence

6

4

4

Abdominal pain

5

2

1

Anorexia

5

2

1

Diarrhea

5

7

4

Ecchymosis

5

2

3

Dyspepsia

5

4

4

Paresthesia

5

2

3

Abnormal dreams

4

1

1

Hallucinations

4

5

3

Ataxia

3

6

1

Dyspnea

3

5

2

Infection

3

2

2

Neck pain

3

1

1

Sweating

3

2

1

Tenosynovitis

3

1

0

Dystonia

3

2

1

Gingivitis

2

1

1

Hemorrhage

2

1

1

Hernia

2

1

1

Myasthenia

2

2

1

*Incidence 2% or greater in AZILECT 1 mg group and numerically more frequent than in placebo group

Several of the more common adverse reactions seemed dose-related, including weight loss, postural hypotension, and dry mouth.

There were no significant differences in the safety profile based on age or gender.

During all Parkinson’s disease phase 2/3 clinical trials, the long-term safety profile was similar to that observed with shorter duration exposure.

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