Sumatriptan nasal spray: a dose‐ranging study in the acute treatment of migraine

Abstract

This multicentre, randomized, double-blind, placebo-controlled, parallel group dose-ranging study compared the efficacy and tolerability of four doses of sumatriptan nasal spray (2.5, 5, 10 and 20 mg) with a placebo, in the acute treatment of a single migraine attack. In total, 544 patients received the study medication as a single spray in one nostril, to treat a single migraine attack in the clinic. Efficacy assessments included the measurement of headache severity, clinical disability, and the presence/absence of associated symptoms. The incidence of headache recurrence was also assessed. The three highest doses of sumatriptan (5 mg 49%, 10 mg 46%, 20 mg 64%) were significantly better than the placebo (25%) at providing headache relief (moderate or severe headache improving to mild or none) 120 min after treatment (P </= 0. 01). Also, the 20 mg dose was significantly superior to both the 10 and 5 mg doses at this time point (P < 0.05). The proportion of patients who were headache-free 120 min after treatment, was also higher following 20 mg (42%) rather than following any other sumatriptan dose (14-24%, P < 0.005 20 vs 10 mg) or placebo (11%). Headache recurrence in patients who had responded to initial treatment was reported by 30-41% of patients who received sumatriptan, compared with 33% of patients in the placebo group. Sumatriptan nasal spray was well tolerated, the incidence of adverse events with each dose of sumatriptan being similar to the placebo (20-27 and 23%, respectively). Apart from bad/bitter taste, the events were comparable with those reported following sumatriptan treatment by other routes of administration.

Sumatriptan Nasal Spray and Cognitive Function During Migraine: Results of an Open‐Label Study

“…Sumatriptan nasal spray (NS), 20 mg, has been shown to be effective for the treatment of acute migraine and its associated symptoms 16‐19 . However, no studies have examined the effect of sumatriptan on cognitive function during acute migraine.…”

The sumatriptan nasal spray: a review of clinical trials

“…2). The figures for clinical disability at 2 h are similar, with 64–74% of patients having no, or only mild clinical disability, significantly better P ≤ 0.05 than the results with placebo (2,4,5) (Fig. 3).…”

“…The results in five studies of the 20 mg intranasal dose (1–5) show that up to 64% of patients on active drug obtained headache relief compared to 25% on placebo; these results being significant at the P ≤ 0.05 level. The figures for achievement of pain‐free status at 2 h were as good as 42%, compared with 12% or less with placebo (Fig.…”

Intranasal absorption of sumatriptan and naratriptan: no evidence of local transfer from the nasal cavities to the brain arterial blood in male rats

“…Local transfer of a drug after nasal administration in man would offer the advantage of a (partly) selective pharmacological treatment of the cranial arteries offering more effect and less side effects. Undocumented local transfer of sumatriptan may thus contribute to the clinical experience that the substance is well tolerated with an incidence of adverse events similar to placebo [11,14].…”