CHANTIX (Page 8 of 10)

14.8 Subjects with Major Depressive Disorder

CHANTIX was evaluated in a randomized, double-blind, placebo-controlled study of subjects aged 18 to 75 years with major depressive disorder without psychotic features (DSM-IV TR). If on medication, subjects were to be on a stable antidepressant regimen for at least two months. If not on medication, subjects were to have experienced a major depressive episode in the past 2 years, which was successfully treated. Subjects were randomized to CHANTIX 1 mg twice daily (N=256) or placebo (N=269) for a treatment of 12 weeks and then followed for 40 weeks post-treatment. Subjects treated with CHANTIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (36%) compared to subjects treated with placebo (16%) and from week 9 through 52 (20%) compared to subjects treated with placebo (10%).

Table 8: Continuous Abstinence (95% confidence interval), Study in Patients with Major Depressive Disorder (MDD)
Weeks 9 through 12 Weeks 9 through 52
CHANTIX1 mg BID Placebo CHANTIX1 mg BID Placebo
BID = twice daily
MDD Study 36% 16% 20% 10%
(30%, 42%) (11%, 20%) (15%, 25%) (7%, 14%)

14.9 Postmarketing Neuropsychiatric Safety Outcome Trial

CHANTIX was evaluated in a randomized, double-blind, active and placebo-controlled trial that included subjects without a history of psychiatric disorder (non-psychiatric cohort, N=3912) and with a history of psychiatric disorder (psychiatric cohort, N=4003). Subjects aged 18–75 years, smoking 10 or more cigarettes per day were randomized 1:1:1:1 to CHANTIX 1 mg BID, bupropion SR 150 mg BID, nicotine replacement therapy patch (NRT) 21 mg/day with taper or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks post-treatment. [See Warnings and Precautions (5.1)]

A composite safety endpoint intended to capture clinically significant neuropsychiatric (NPS) adverse events included the following NPS adverse events: anxiety, depression, feeling abnormal, hostility, agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, irritability, suicidal ideation, suicidal behavior or completed suicide.

As shown in Table 9, the use of CHANTIX, bupropion, and NRT in the non-psychiatric cohort was not associated with an increased risk of clinically significant NPS adverse events compared with placebo. Similarly, in the non-psychiatric cohort, the use of CHANTIX was not associated with an increased risk of clinically significant NPS adverse events in the composite safety endpoint compared with bupropion or NRT.

Table 9. Number of Patients with Clinically Significant or Serious NPS Adverse Events by Treatment Group Among Patients without a History of Psychiatric Disorder
CHANTIX(N=975)n (%) Bupropion(N=968)n (%) NRT(N=987)n (%) Placebo(N=982)n (%)
Clinically significant NPS 30 (3.1) 34 (3.5) 33 (3.3) 40 (4.1)
Serious NPS 1 (0.1) 5 (0.5) 1 (0.1) 4 (0.4)
Psychiatric hospitalizations 1 (0.1) 2 (0.2) 0 (0.0) 1 (0.1)

As shown in Table 10, there were more clinically significant NPS adverse events reported in patients in the psychiatric cohort in each treatment group compared with the non-psychiatric cohort (Table 9). The incidence of events in the composite endpoint was higher for each of the active treatments compared to placebo: Risk Differences (RDs) (95%CI) vs placebo were 2.7% (-0.05, 5.4) for CHANTIX, 2.2% (-0.5, 4.9) for bupropion, and 0.4% (-2.2, 3.0) for NRT transdermal nicotine.

Table 10. Number of Patients with Clinically Significant or Serious NPS Adverse Events by Treatment Group Among Patients with a History of Psychiatric Disorder
CHANTIX(N=1007)n (%) Bupropion(N=1004)n (%) NRT(N=995)n (%) Placebo(N=997)n (%)
Clinically Significant NPS 123 (12.2) 118 (11.8) 98 (9.8) 95 (9.5)
Serious NPS 6 (0.6) 8 (0.8) 4 (0.4) 6 (0.6)
Psychiatric hospitalizations 5 (0.5) 8 (0.8) 4 (0.4) 2 (0.2)

There was one completed suicide, which occurred during treatment in a patient treated with placebo in the non-psychiatric cohort. There were no completed suicides reported in the psychiatric cohort.

In both cohorts, subjects treated with CHANTIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 and 9 through 24 compared to subjects treated with bupropion, nicotine patch and placebo.

Table 11: Continuous Abstinence (95% confidence interval), Study in Patients with or without a History of Psychiatric Disorder
CHANTIX1 mg BID Bupropion SR150 mg BID NRT21 mg/day with taper Placebo
BID = twice daily
Weeks 9 through 12
Non-Psychiatric Cohort 38%(35%, 41%) 26%(23%, 29%) 26%(24%, 29%) 14%(12%, 16%)
Psychiatric Cohort 29%(26%, 32%) 19%(17%, 22%) 20%(18%, 23%) 11%(10%, 14%)
Weeks 9 through 24
Non-Psychiatric Cohort 25%(23%, 28%) 19%(16%, 21%) 18%(16%, 21%) 11%(9%, 13%)
Psychiatric Cohort 18%(16%, 21%) 14%(12%, 16%) 13%(11%, 15%) 8%(7%, 10%)

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