(Stamped: Feb 17 1995)

 

Statistical Review and Evaluation

 

 

NDA#:           20-358/3-S

 

Sponsor:                        Burroughs-Wellcome

 

Name of Drug:                        Wellbutrin SR

 

Document Reviewed: Vols 2.29, 2.46, Vol 11 dated 12/23/94

 

Medical Officer; Dan Oren, M.D., HFD-120

 

The sponsor has submitted 3 multidose, placebo controlled studies (203, 205, 212) of a sustained release formulation of Wellbutrin.  Statistically significant results are scattered over various time points for several variables within each study.  See Dr. Oren’s review for study descriptions and a summary of results.  No consistent or coherent evidence of efficacy emerges from this wealth of information.  This reviewer performed a simple meta-analysis using these three studies in order to investigate whether strength of numbers would reveal a signal in the data.

 

This meta-analysis used the (change from baseline) HAMD 28 at 8 weeks for both observed cases and LOCF analyses.  The treatment comparison was 300 mg vs PBO since 300 mg was near the high end and 300 mg was the dose common to all three trials.  The 95% confidence intervals below are for the treatment difference between changes from baseline.  All results are in the direction favorable for the drug.

 

		LOCF	OBSERVED CASES
	Spons’ p-value	.051	.16
203	Conf Int	(-5.6, 0.14)	(.5.85, 1.31)
	Post Hoc power	.46	.24
	Spons’ p-value	.39	.03
205	Conf Int	(-4.5, 1.5)	(-7.2, 0.04)
	Post Hoc power	.16	.49
	Spons’ p-value	.25	.14
212	Conf Int	(-4.1, 1.0)	(-5.2, 0.7)
	Post Hoc power	.21	.32

 

 

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