Wellbutrin SR® Summary Basis of Approval NDA 20-358

Enclosure 3

NDA 20-358

WELLBUTRIN SR (bupropion hydrochloride) Tablets

Table 2 Summary of Significance Levels¹ (2-sided) for Pairwise Comparisons (Bupropion SR vs Placebo) in Study 205
Key Outcome Variables	Bupropion SR Dose Groups
	100 mg								200 mg								300 mg								400 mg
	Week²								Week								Week								Week
	1	2	3	4	5	6	7	8	1	2	3	4	5	6	7	8	1	2	3	4	5	6	7	8	1	2	3	4	5	6	7	8
HAMD-17
LOCF	-	-	-	t	t	t	*	*	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	*	-	-	-	-	-	-	-
OC	-	-	-	t	-	-	t	t	-	-	-	-	-	-	-	-	-	-	*	t	-	t	*	t	*	-	t	-	-	-	*	*
HAMD-28
LOCF	-	-	t	t	*	*	*	*	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
OC	-	-	t	-	-	t	t	t	-	-	-	-	-	-	t	-	-	-	*	t	-	*	*	*	-	-	t	t	-	-	*	*
HAMD Item 1
LOCF	-	-	-	-	t	*	t	-	-	t	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	t	-	-	-	-
OC	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	t	-	-	-	-	-	-	-	-	t	-	t	-	*
CGI-S
LOCF	-	-	*	t	t	*	*	*	-	-	-	-	-	-	-	-	t	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
OC	-	-	*	-	t	t	t	-	-	-	-	-	-	-	-	-	t	t	*	-	t	t	-	-	-	-	-	-	-	-	-	t
CGI-I
LOCF	-	-	t	-	t	t	*	*	t	-	-	t	t	*	*	t	t	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
OC	-	-	t	-	-	t	*	t	t	-	-	-	-	t	**	-	t	-	*	t	t	*	**	t	-	-		t	t-	-	**	-

1	*	=	p	≤	0.05
	t	=	p	≤	0.10
	-	=	p	>	0.10
	**	=	p	≥	0.025 (criterion p-value for Dunnett’s Test **(Original symbol shaded . Changed for purpose of re-entering this document.)***

2	End of weeks 1-8