Sumatriptan Succinate (Page 5 of 6)

14.1 Migraine

In controlled clinical trials enrolling more than 1,000 subjects during migraine attacks who were experiencing moderate or severe pain and 1 or more of the symptoms enumerated in Table 3, onset of relief began as early as 10 minutes following a 6 mg sumatriptan succinate injection. Lower doses of sumatriptan succinate injection may also prove effective, although the proportion of subjects obtaining adequate relief was decreased and the latency to that relief is greater with lower doses.

In Study 1, 6 different doses of sumatriptan succinate injection (n = 30 each group) were compared with placebo (n = 62), in a single-attack, parallel-group design, the dose response relationship was found to be as shown in Table 2.

Table 2. Proportion of Subjects with Migraine Relief and Incidence of Adverse Events by Time and by Sumatriptan Succinate Dose in Study 1

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

a 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 randomized, placebo-controlled clinical trials of sumatriptan succinate injection 6 mg in 1,104 subjects with moderate or severe migraine pain (Studies 2 and 3), the onset of relief was less than 10 minutes. Headache relief, as defined by a reduction in pain from severe or moderately severe to mild or no headache, was achieved in 70% of the subjects within 1 hour of a single 6 mg subcutaneous dose of sumatriptan succinate injection. Approximately 82% and 65% of subjects treated with sumatriptan succinate 6 mg had headache relief and were pain free within 2 hours, respectively.

Table 3 shows the 1- and 2-hour efficacy results for sumatriptan succinate injection 6 mg in Studies 2 and 3.

Table 3. Proportion of Subjects with Pain Relief and Relief of Migraine Symptoms after 1 and 2 Hours of Treatment in Studies 2 and 3

1-Hour Data Study2 Study 3
Placebo (n = 190) Sumatriptan Succinate 6 mg (n = 384) Placebo (n = 180) Sumatriptan Succinate 6 mg (n = 350)
Subjects with pain relief (grade 0/1) Subjects with no pain Subjects without nausea Subjects without photophobia Subjects with little or no clinical disability b 18% 5% 48% 23% 34% 70% a 48% a 73% a 56% a 76% a 26% 13% 50% 25% 34% 70% a 49% a 73% a 58% a 76% a
2-Hour Data Study2 Study 3
Placebo c Sumatriptan Succinate 6 mg d Placebo c Sumatriptan Succinate 6 mg d
Subjects with pain relief (grade 0/1) Subjects with no pain Subjects without nausea Subjects without photophobia Subjects with little or no clinical disability b 31% 11% 56% 31% 42% 81% a 63% a 82% a 72% a 85% a 39% 19% 63% 35% 49% 82% a 65% a 81% a 71% a 84% a

a P <0.05 versus placebo.

b A successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impaired or ability to work and function normally.

c Includes subjects that may have received an additional placebo injection 1 hour after the initial injection.

d Includes subjects that may have received an additional 6 mg of sumatriptan succinate injection 1 hour after the initial injection.

Sumatriptan succinate injection also relieved photophobia, phonophobia (sound sensitivity), nausea, and vomiting associated with migraine attacks.

The efficacy of sumatriptan succinate injection was unaffected by whether or not the migraine was associated with aura, duration of attack, gender or age of the subject, or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers).

14.2 Cluster Headache

The efficacy of sumatriptan succinate injection in the acute treatment of cluster headache was demonstrated in 2 randomized, double-blind, placebo-controlled, 2-period crossover trials (Studies 4 and 5). Subjects aged 21 to 65 years were enrolled and were instructed to treat a moderate to very severe headache within 10 minutes of onset. Headache relief was defined as a reduction in headache severity to mild or no pain. In both trials, the proportion of individuals gaining relief at 10 or 15 minutes was significantly greater among subjects receiving 6 mg of sumatriptan succinate injection compared with those who received placebo (see Table 4).

Table 4. Proportion of Subjects with Cluster Headache Relief by Time in Studies 4 and 5

Study 4 Study 5
Placebo (n = 39) Sumatriptan Succinate 6 mg (n = 39) Placebo (n = 88) Sumatriptan Succinate 6 mg (n = 92)
Subjects with pain relief (no/mild) 5 Minutes post-injection 10 Minutes post-injection 15 Minutes post-injection 8% 10% 26% 21% 49% a 74% a 7% 25% 35% 23% a 49% a 75% a

a P <0.05.

(n = Number of headaches treated.)

An estimate of the cumulative probability of a subject with a cluster headache obtaining relief after being treated with either sumatriptan succinate injection or placebo is presented in Figure 1.

Figure 1. Time to Relief of Cluster Headache from Time of Injection a

figure 1
(click image for full-size original)

a The figure uses Kaplan-Meier (product limit) Survivorship Plot. Subjects taking rescue medication were censored at 15 minutes.

The plot was constructed with data from subjects who either experienced relief or did not require (request) rescue medication within a period of 2 hours following treatment. As a consequence, the data in the plot are derived from only a subset of the 258 headaches treated (rescue medication was required in 52 of the 127 placebo-treated headaches and 18 of the 131 headaches treated with sumatriptan succinate injection).

Other data suggest that treatment with sumatriptan succinate injection is not associated with an increase in early recurrence of headache and has little effect on the incidence of later-occurring headaches (i.e., those occurring after 2, but before 18 or 24 hours).

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