title: An open-label trial of a sumatriptan auto-injector for migraine in patients currently treated with subcutaneous sumatriptan.
abstract: OBJECTIVE
  To assess the ability of patients, during an acute migraine attack, to successfully self-inject a single dose of sumatriptan using a novel sumatriptan auto-injector (Alsuma(®)), and to evaluate the safety, tolerability, and effectiveness of this sumatriptan auto-injector during an acute migraine attack.
  
  
  BACKGROUND
  This sumatriptan auto-injector is a single-use system for the rapid subcutaneous delivery of 6 mg of sumatriptan succinate in the acute management of migraine pain. This auto-injector was developed to address the clinical need for an easy-to-use and rapid-to-administer system that did not require any assembly during the time of an ongoing attack.
  
  
  METHODS
  This was an open-label, phase 3 trial conducted at 10 sites in the USA. Male or female adults, ages 18-60 years old, were eligible for study entry if they met International Headache Society criteria for migraine with or without aura, with at least 2 attacks per month, and if they reported use of subcutaneous injectable sumatriptan on at least 2 occasions within the previous 2 months. During the onset of a migraine attack of moderate-to-severe intensity, patients were asked to administer a 6-mg subcutaneous dose of sumatriptan using the auto-injector. Patients returned to the study site within 72 hours of the migraine for the post-treatment assessment visit.
  
  
  RESULTS
  A total of 63 patients met entry criteria and received a dose of study medication (the intent-to-treat sample). Sixty-one patients (96.8%) reported injection in the thigh, and 2 patients (3.2%) reported injection in the arm. On the patient questionnaire, 100% of patients (95% confidence interval [CI] 94.3-100%) "agreed" or "agreed strongly" that the written instructions for the auto-injector were clear and easy to follow (30.2% "agreed"; 69.8% "agreed strongly"); 95.2% of patients (95% CI 86.7-99.0%) found that the auto-injector was easy to use (36.5% "agreed"; 58.7% "agreed strongly"), and 65.1% of patients (95% CI 52.0-76.7%) stated that they preferred the new auto-injector to the traditional auto-injector that they were using prior to study entry (42.9% "agreed"; 22.2% "agreed strongly"). Headache response rate at 2 hours was 93.7% (95% CI 84.5-98.2%), and pain-free rate at 2 hours was 60.3% (95% CI 47.2-72.4%). Pain-free rates at 2 hours were similarly high (58.3%; 95% CI 36.6-77.9%) in the subgroup of patients reporting severe baseline headache pain. Only 1 patient reported use of rescue medication after use of the auto-injector, a single oral dose of sumatriptan 100 mg on the same day. The most frequent adverse event was injection site bruising, reported by 15.9% of patients, and rated in all instance as mild in intensity. The second most frequent adverse event was injection site pain, reported by 6.3% of patients, and rated as mild by all patients except 1, who rated it as moderate in intensity.
  
  
  CONCLUSIONS
  The majority of injection-experienced patients reported the pre-assembled, single-use sumatriptan auto-injector to be an easy-to-use, preferred treatment for an acute migraine attack. The study found the auto-injector to be safe and well tolerated, with levels of injection site reactions that were mild and infrequent.
authors.affiliation: Wesley Neurology Clinic, Memphis, TN, USA.
authors.forename: Stephen H
authors.initials: SH
authors.lastname: Landy
authors.affiliation: Neurological Center for Pain, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Stewart J
authors.initials: SJ
authors.lastname: Tepper
authors.affiliation: Division of Neurology, Montreal General Hospital, Montreal, QC, Canada.
authors.forename: Theodore
authors.initials: T
authors.lastname: Wein
authors.affiliation: Paladin Consulting Group, Princeton, NJ, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Schweizer
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: Elodie
authors.initials: E
authors.lastname: Ramos
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous / Q000379:methods*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D018170:Sumatriptan / Q000008:administration & dosage* / Q000009:adverse effects; D014662:Vasoconstrictor Agents / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D014662:Vasoconstrictor Agents; D018170:Sumatriptan