B.     Exposures, Deaths, SAE, Discontinuations due to AE, and Common AE in the Bioavailability Studies

In the 5 bioavailability studies, 173 normal subjects were exposed to either single or multiple doses of WELLBUTRIN XL 300 mg for up to 10 days.  The total exposure to WELLBUTRIN XL 300 mg was 3.43 patient-years.

 

There were no deaths, serious adverse events, new or unexpected adverse events compared with adverse events that have been reported and labeled for the bupropion immediate release and sustained-release formulations.  Discontinuations due to adverse events are described in the table below.

 

Table 1.  Safety Parameters for the 5 Bioavailability Studies with WELLBUTRIN XL

Study #	BIOAVAIL-2543	BIOAVAIL-2544	BIOAVAIL-2548	BIOAVAIL-2571	BIOAVAIL-2526
Parameter
Subjects Entered	40	40	36	36	21
Sub. Completed	30	37	32	35	20
Exposure to WELLBUTRIN XL (300 mg)*	1.12 pt – years	1.01 pt – years	0.2 pt – years	0.2 pt – years	0.9 pt – years
Deaths	None	None	None	None	None
Serious Adverse Events	None	None	None	None	None
Discontinuations due to AE (XL)	Two: Dysuria, urinary urgency   Pruritis, rash	One: Pharyngitis, fever, leukocytosis	Two: Swollen hand, arthritis   Contusion from venipuncture	None	One: Constipation, Nausea, bloating

*Total exposure to WELLBUTRIN XL in the above studies = 3.43 pt-years

 

In 3 of the 5 studies, the immediate-release formulation of bupropion (300 mg) was used as a comparator.  There were no placebo groups for comparison.

 

The most common adverse events reported during WELLBUTRIN XL administration were: headache, constipation, nausea, abdominal pain or discomfort, rash, tremor, and dizziness.  The safety and tolerability profile of WELLBUTRIN XL appears to be quite similar to those of WELLBUTRIN IR and WELLBUTRIN SR.  Please refer to the table below.

 

 

3

 

 

 

 

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