|
Table 5.1.3.2 Number and Percentage of
All Patients Receiving Bupropion Sustained-Release According to Mean Daily
Dose and Duration in all Phase 2 and 3 Studies* |
|||||||
|
Duration
(days) |
100
mg |
150
mg |
200
mg |
300
mg |
400
mg |
Total |
Percentage* |
|
1-6 |
144 |
10 |
0 |
3 |
0 |
157 |
4.2% |
|
7-13 |
48 |
102 |
101 |
18 |
1 |
270 |
7.2% |
|
14-20 |
20 |
27 |
166 |
16 |
8 |
237 |
6.3% |
|
21-27 |
10 |
26 |
74 |
45 |
5 |
160 |
4.3% |
|
28-34 |
9 |
21 |
58 |
77 |
4 |
169 |
4.5% |
|
35-41 |
8 |
11 |
34 |
64 |
1 |
118 |
3.2% |
|
42-48 |
6 |
11 |
22 |
46 |
1 |
86 |
2.3% |
|
49-55 |
36 |
39 |
94 |
283 |
23 |
475 |
12.7% |
|
≥56** |
87 |
99 |
368 |
1461 |
48 |
2063 |
55.2% |
|
Total |
368 |
346 |
917 |
2013 |
91 |
3735 |
|
|
Percentage |
9.9% |
9.3% |
24.5% |
53.9% |
2.4% |
|
100 |
*A
total of 22 patients from Study 205 did not receive study medication beyond the
initial titration period and a total of 36 patients from Study 208 did not have
dosing records for the mean daily dose calculations. These 56 patients were excluded from the above table.
**A
total of 1577 patients entered the Continuation Phase beginning at day 56 of
Study 208, but these data were not available at the time of submission of the
study report on the eight-week trial.
All exposure to bupropion sustained-release in studies 203 and 205 ended
after eight weeks.
5.2
Secondary Sources
5.2.1
Post-marketing Experience
As
of June 15, 1994, bupropion sustained release had not been marketed in any
country.
5.2.2
Literature
In
a literature search by this reviewer using the FDA Library Medline program,
there were no clinical research publications found pertaining to bupropion
sustained-release. The NDA itself
contained no literature review of the immediate release form of bupropion.
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