[page as written]

 

relationship, and do not provide statistically significant evidence of the effect of bupropion sustained-release. On balance, although no specific standard of efficacy was established in the design of this study, the data from protocol 212 failed to show convincing evidence of the efficacy of either of the two doses of bupropion sustained-release that were tested.

 

AD7.3.2                                Size of Treatment Effect

 

The relative effect of bupropion sustained-release as compared with placebo was slight.  In protocol 212 the mean decrease from baseline in 21-item HAMD was 14 for bupropion sustained-release and 12 for placebo at endpoint.

 

AD8.0                                Safety Findings

 

AD8.1                                Methods

 

Safety assessments from study 212 were derived from 302 patients who were exposed to bupropion sustained-release, with the exception of 8 patients for whom no treatment phase assessments were available.

 

Safety issues were evaluated on the basis of these data sets and case report forms.  Uncommon, severe adverse events were assessed using premature discontinuations from clinical trials and “serious” adverse events (as defined below), while more common but less grave adverse reactions were identified through routinely collected safety data.  Section AD8.6 contains a discussion of those adverse events deemed both significant and potentially drug-related.

 

AD8.2                                Deaths

 

None were reported.

 

AD8.3                                Assessment of Dropouts

 

AD8.3.1                                Overall Patterns of Dropouts

 

Table AD8.3.1 summarizes reasons for premature discontinuation among patients who were randomly assigned to receive treatment under protocol 212.  This table was compiled by reviewing the reasons assigned by the individual investigators for each subject who dropped out.  In several cases where “Consent Withdrawn” was assigned by the investigator as a reason for withdrawal, but where the case reports or narrative case summaries suggested to this reviewer that “Lack of Efficacy” or “Adverse Experiences” better captured the reason for dropping out, one of the latter two explanations was used in the table.

 

 

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