Sumatriptan nasal spray for the acute treatment of migraine

Abstract

Sumatriptan nasal spray may be particularly useful for patients whose nausea and vomiting preclude them from using oral migraine medication or for patients who prefer not to use an injectable migraine medication. The objective of this study was to evaluate in two clinical studies the efficacy and tolerability of the intranasal form of sumatriptan in the acute treatment of a single migraine attack. International Headache Society-diagnosed adult migraineurs in two randomized, double-blind, parallel-group, multicenter studies (n = 409 and 436) used sumatriptan nasal spray 20 mg, 10 mg, or placebo (2:1:1) for the acute treatment of a single migraine attack at home. Predose and at predetermined postdose intervals, patients recorded headache severity (none, mild, moderate, severe); time to meaningful relief; clinical disability (none, mildly impaired, severely impaired, bed rest required); presence/absence of nausea, photophobia, and phonophobia; and the occurrence of adverse events. Two hours postdose in the two studies, moderate or severe baseline pain was reduced to mild or none in 62 to 63% of patients treated with sumatriptan 20 mg, 43 to 54% of patients treated with sumatriptan 10 mg, and 29 to 35% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies and 10 mg versus placebo for study 1). Onset of relief relative to placebo began as early as 15 minutes postdose (sumatriptan 20 mg, study 2). Clinical disability at 2 hours postdose was reported as mildly impaired or normal in 72 to 74% of patients treated with sumatriptan 20 mg, 56 to 68% of patients treated with sumatriptan 10 mg, and 47 to 58% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies). Similar efficacy rates were observed for nausea, photophobia, and phonophobia. The most common adverse event in the active treatment groups was disturbance of taste (bad, bitter, or unpleasant taste). Aside from this event, the pattern and incidence of adverse events did not differ among treatment groups. From these results we determined that sumatriptan nasal spray is a rapidly effective, well-tolerated migraine treatment. The 20-mg dose was effective in treating the entire migraine symptom complex, and the 10-mg dose was less consistently effective.

Thermoreversible-mucoadhesive Gel for nasal delivery of sumatriptan

“…The upper probe was attached to precalibrated force displacement transducer SS12LA, (BIOPAC Systems Inc, Santa Barbara, CA) connected to the Biopac MP-30 data acquisition system (BIOPAC Systems). The surface area of each exposed mucosal membrane was 0.785cm 2 . At room temperature, fixed amount of samples of each formulation were placed on the lower probe.…”

“…Tissue samples were inserted in Franz diffusion cells displaying a permeation area of 0.785 cm 2 . Twenty milliliters of phosphate buffer saline (PBS) pH 6.4 at 34-C was added to the acceptor chamber.…”

“…Although sumatriptan nasal spray provides faster onset of effect than the tablet, it produces a similar headache response at 2 hours. 2 Recently, an intranasal-microemulsion drug delivery system to accomplish rapid delivery of sumatriptan to the brain in acute attacks of migraine has been reported. 3 Hence, a formulation that would increase residence time in the nasal cavity and at the same time increase absorption of the drug would be highly beneficial in all respects.…”

Development ofin situgel for nasal delivery: design, optimization,in vitroandin vivoevaluation

“…Moreover, the transport of sumatriptan across the blood-brain barrier is very poor. After 15 minutes, sumatriptan solution is swallowed and it enters the gastrointestinal tract where remaining dose is absorbed, which may get increased by intranasal delivery (Ryan et al, 1997;Majithiya et al, 2006). An intranasal-microemulsion drug delivery system to accomplish rapid delivery of sumatriptan to the brain in acute attacks of migraine has been reported (Vyas et al, 2005).…”

Clinical Study Shows Improved Absorption of Desmopressin with Novel Formulation

“…The sensation will vary depending on the carrier powder and amount thereof and may even be less irritating than the corresponding liquid spray (32). The fact that the powder spray did not run down the throat was acknowledged by the volunteers and it is possible that the formulation would have seemed even more advantageous, had it been compared with a liquid spray containing a drug such as sumatriptan, which is known to have a bad taste (33).…”