Conflict of Interest: Dr. Schweizer is the owner of Paladin Consulting Group, Inc., which was a paid consultant to Pfizer, Inc. in connection with the development of this manuscript. Dr. Ramos is an employee of Pfizer, Inc.
An Open-Label Trial of a Sumatriptan Auto-Injector for Migraine in Patients Currently Treated With Subcutaneous Sumatriptan†
Article first published online: 13 NOV 2012
© 2012 American Headache Society
Headache: The Journal of Head and Face Pain
Volume 53, Issue 1, pages 118–125, January 2013
How to Cite
Landy, S. H., Tepper, S. J., Wein, T., Schweizer, E. and Ramos, E. (2013), An Open-Label Trial of a Sumatriptan Auto-Injector for Migraine in Patients Currently Treated With Subcutaneous Sumatriptan. Headache: The Journal of Head and Face Pain, 53: 118–125. doi: 10.1111/j.1526-4610.2012.02295.x
Clinicaltrials.gov indentifier: NCT00510419.
This study was sponsored by King Pharmaceuticals®, Inc., which was acquired by Pfizer, Inc. in March 2011.
- Issue published online: 8 JAN 2013
- Article first published online: 13 NOV 2012
- Manuscript Accepted: 26 SEP 2012
- migraine headache;
- headache disorder
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.
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.
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.
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.
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.