7.3.3
Choice of Dose
None of the doses studied in protocols 203 and 205 was unequivocally an effective treatment based on the parametric analyses of the individual studies. (The largest data base on any individual dosage of bupropion sustained-release is that based on the subjects who received 300 mg/day of the medication the approved standard daily dosage for bupropion immediate-release.)
7.3.4
Duration of Treatment
Both
studies 203 and 205 suggest that periods of four weeks or less are inadequate
to demonstrate efficacy of bupropion sustained-release with the sample sizes
used.
7.4
Conclusions Regarding Efficacy Data
Protocols
203 and 205 both fail to show unequivocal evidence of the efficacy of the doses
of bupropion sustained-release that were tested.
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