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Imitrex Inj

Clinical Pharmacology
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Clinical Pharmacology

Imitrex Inj

In 1 well-controlled study where placebo (n = 62) was compared to 6 different doses of IMITREX Injection (n = 30 each group) in a single-attack, parallel-group design, the dose response relationship was found to be as shown in Table 1.

Table 1. Dose Response Relationship for Efficacy

IMITREX
Dose (mg)
% Patients
With Relief*
at 10 Minutes
% Patients
With Relief*
at 30 Minutes
% Patients
With Relief*
at 1 Hour
% Patients
With Relief*
at 2 Hours
Adverse
Events
Incidence (%)
Placebo
5
15
24
21
55
1
10
40
43
40
63
2
7
23
57
43
63
3
17
47
57
60
77
4
13
37
50
57
80
6
10
63
73
70
83
8
23
57
80
83
93

* Relief is defined as the reduction of moderate or severe pain to no or mild pain after dosing without use of rescue medication.

In 2 US well-controlled clinical trials in 1,104 migraine patients with moderate or severe migraine pain, the onset of relief was rapid (less than 10 minutes) with IMITREX Injection 6 mg. Headache relief, as evidenced by a reduction in pain from severe or moderately severe to mild or no headache, was achieved in 70% of the patients within 1 hour of a single 6-mg subcutaneous dose of IMITREX Injection. Headache relief was achieved in approximately 82% of patients within 2 hours, and 65% of all patients were pain free within 2 hours.

Table 2 shows the 1- and 2-hour efficacy results for IMITREX Injection 6 mg.

Table 2. Efficacy Data From US Phase III Trials

1-Hour Data
Study 1
Study 2
Placebo
(n = 190)
IMITREX 6 mg
(n = 384)
Placebo
(n = 180)
IMITREX 6 mg
(n = 350)
Patients with pain relief (grade
0/1)
18%
70%*
26%
70%*
Patients with no pain
5%
48%*
13%
49%*
Patients without nausea
48%
73%*
50%
73%*
Patients without photophobia
23%
56%*
25%
58%*
Patients with little or no clinical
disability§
34%
76%*
34%
76%*
2-Hour Data
Study 1
Study 2
Placebo†
IMITREX 6 mg†
Placebo†
IMITREX 6 mg†
Patients with pain relief (grade
0/1)
31%
81%*
39%
82%*
Patients with no pain
11%
63%*
19%
65%*
Patients without nausea
56%
82%*
63%
81%*
Patients without photophobia
31%
72%*
35%
71%*
Patients with little or no clinical
disability§
42%
85%*
49%
84%*
Brand Name: Imitrex Inj
Generic Name: Sumatriptan Succinate
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