Review of Complete Response to Approvable Letter

 

Sponsor:                                              GlaxoSmithKline

Drug:                                                   WELLBUTRIN XL (bupropion extend. Release)

NDA:                                                   21-515

Material Submitted:                           Safety Update; Proposed Labeling

Correspondence Date:                       June 27, 2003

Date Received:                                   July 3, 2003

Drug Category:                                   Antidepressant

Forms available for proposed study:  150 mg & 300 mg tablets

Related NDAs and ID:                       18,644,  20,258,  28,676

 

 

1.         Overview and Summary of Safety Conclusions

With this submission, the sponsor has responded to the Division’s Approvable Letter dated June 24, 2003.  The Division requested that the sponsor provide a safety update, as well as proposed changes to labeling and the patient package insert.  This review will focus on the safety update for WELLBUTRIN XL.

 

The safety update includes safety data from completed and ongoing studies for the period April 2, 2003 through June 6, 2003.  The sponsor has provided appropriated data for the safety update regarding six clinical trials.  Generally, WELLBUTRIN XL appears to be reasonably safe and well tolerated.  During the interval indicated above, there were no deaths.  There were 3 serious adverse events, 19 discontinuations due to adverse events, and one pregnancy during the trials.   Probably because treatment assignments remain blinded, the sponsor did not submit data regarding commonly reported adverse events for these trials.  The sponsor did not provide information about reasons for discontinuation due to adverse events for most of the cases.

 

II.     Review of Safety Update for WELLBUTRIN XL

A.       Description of Clinical Data and Sources

The safety information reviewed included summaries of safety findings and narratives of specific cases.  There are six relevant studies.  One is a bioavailability study (AKBIOVAIL2572), involving 54 healthy subjects, in which the PK profiles of WELLBUTRIN XL and SR were compared.  There are two clinical trials comparing the effects on sexual functioning of (300-450mg) and Escitalopram (10-20mg) in subjects with depression (AK130926 and AK130927).  A total of 202 subjects were enrolled as of June 6, 2003.  Two trials are studying the efficacy of WELLBUTRIN XL in the prevention of Seasonal Affective Disorder (AK 130930 and AK130936).  A total of 614 subjects were enrolled as of June 6, 2003.  Finally, one trial is assessing the efficacy of WELLBUTRIN XL in adults with Attention-Deficit Hyperactivity Disorder.  A total of 162 202 subjects were enrolled as of June 6, 2003.

 

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