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As Of Filer Filing For·On·As Docs:Size Issuer Agent 6/26/06 New River Pharmaceuticals Inc 8-K:8,9 6/26/06 2:1.1M Summit Fin’l Printing |
Document/Exhibit Description Pages Size 1: 8-K New River Pharmaceutical 8-K 6-26-2006 HTML 22K 2: EX-99.1 Miscellaneous Exhibit HTML 177K
Exhibit 99.1 |
Cohort
|
Placebo
|
d-Amphetamine,
mg
|
NRP104,
mg
|
|||||
1
|
Yes
|
40
|
30
|
50
|
70
|
100
|
|
|
2
|
Yes
|
40
|
|
50
|
70
|
100
|
130
|
|
3
|
Yes
|
40
|
|
|
70
|
100
|
130
|
150
|
Characteristic
|
N
= 12
|
Age,
years
Mean
± SD
Median
(range)
|
43
± 5.9
44
(29 - 52)
|
Sex,
n (%)
Male
|
12
(100)
|
Race,
n (%)
White
Black
Asian
|
1
(8.3)
10
(83.3)
1
(8.3)
|
Height,
cm
Mean
± SD
Median
(range)
|
172.8
± 6.7
174
(160 - 183)
|
Weight,
kg
Mean
± SD
Median
(range)
|
74.6
± 10.8
72
(58 - 94)
|
REALM
test score
Mean
± SD
Median
(range)
|
61.8
± 7.6
64.5
(43 - 66)
|
Cohort
|
Subject,
n
|
NRP104
|
d-amphetamine
|
Placebo
|
1
|
3
|
25
mg
|
10
mg
|
Yes
|
2
|
9
|
50
mg
|
20
mg
|
Yes
|
Characteristic
|
N
= 12
|
Age,
years
Mean
± SD
Median
(range)
|
45.9
± 3.3
45.5
(42 - 52)
|
Sex,
n (%)
Male
|
12
(100)
|
Race,
n (%)
White
Black
|
1
(8)
11
(92)
|
Height,
cm
Mean
± SD
Median
(range)
|
176
± 7.1
175.7
(159.5 - 185.4)
|
Weight,
kg
Mean
± SD
Median
(range)
|
69.5
± 10.3
68.8
(53.5 - 91.2)
|
Drug
Chosen to Take Again
|
||
|
Subject
|
Drug
|
1
|
1
|
d-amphetamine
10 mg
|
2
|
3
|
d-amphetamine
10 mg
|
3
|
4
|
d-amphetamine
10 mg
|
|
Mean
± SD
|
|
Parameters
|
NRP104
25 mg
(n
= 3)
|
NRP104
50 mg
(n
= 9)
|
T1/2,
h
|
0.72
± 0.09
|
1.25
± 1.13
|
AUC0-24,
ng·hr/mL
|
281.9
± 104.0
|
598.7
± 232.9
|
Cmax,
ng/mL
|
1150
± 710
|
1570
± 779
|
Tmax,
hr
|
0.09
± 0.01
|
0.18
± 0.20
|
Drug
Chosen to Take Again
|
||
Subject
|
Drug
|
|
1
|
2
|
None
of the treatments
|
2
|
5
|
d-amphetamine
20 mg
|
3
|
6
|
d-amphetamine
20 mg
|
4
|
7
|
None
of the treatments
|
5
|
8
|
NRP104
50 mg
|
6
|
9
|
d-amphetamine
20 mg
|
7
|
10
|
d-amphetamine
20 mg
|
8
|
11
|
d-amphetamine
20 mg
|
9
|
12
|
d-amphetamine
20 mg
|
Drug
(I)
|
Drug
(J)
|
Mean
Difference
(I
- J)
|
Std.
Error
|
Significance
|
95%
Conf.
Interval
(Lower
Bound)
|
d-amphetamine
40 mg
|
Placebo
|
4.53*
|
1.148
|
<
0.001
|
1.94
|
diethylpropion
200 mg
|
Placebo
|
4.03*
|
1.148
|
0.001
|
1.44
|
LDX
100 mg
|
Placebo
|
2.14
|
1.148
|
0.113
|
-0.45
|
Drug
(I)
|
Drug
(J)
|
Mean
Difference
(I
- J)
|
Std.
Error
|
Significance
|
95%
Conf.
Interval
(Lower
Bound)
|
LDX
50 mg
|
Placebo
|
1.97
|
1.148
|
0.148
|
-0.61
|
LDX
100 mg
|
Placebo
|
2.14
|
1.148
|
0.113
|
-0.45
|
LDX
150 mg
|
Placebo
|
6.06*
|
1.148
|
0.001
|
3.47
|
This ‘8-K’ Filing | Date | Other Filings | ||
---|---|---|---|---|
Filed on / For Period End: | 6/26/06 | |||
3/15/06 | 10-K | |||
List all Filings |