title: Needle-free subcutaneous sumatriptan: in the acute treatment of migraine attacks or cluster headache episodes.
abstract: A needle-free device for delivering a 6 mg fixed dose of sumatriptan into subcutaneous tissues has been developed and approved for the acute treatment of migraine and cluster headache in the US and some EU countries. In a pivotal registration study in healthy adult volunteers, a single dose of needle-free subcutaneous sumatriptan 6 mg demonstrated bioequivalence to a single dose of traditional, needle-based subcutaneous sumatriptan 6 mg when delivered into the abdomen or the thigh, but not the arm. In a noncomparative, multicentre, phase IV study, the administration of (one or two doses of) needle-free subcutaneous sumatriptan 6 mg consistently provided rapid and sustained relief from migraine pain and associated symptoms during the treatment of up to four migraine attacks over a period of up to 60 days among current triptan users. Moreover, the use of needle-free subcutaneous sumatriptan was associated with a significant improvement in treatment satisfaction in these patients who were less than 'very satisfied' with their usual symptomatic therapy. Needle-free subcutaneous sumatriptan was generally well tolerated in the phase IV study. Although the overall adverse event profile of the needle-free delivery system was similar to that previously reported for the needle-based delivery system, it was associated with a numerically higher incidence of administration/injection-site reactions in clinical trials that enrolled healthy adult volunteers.
authors: Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz
authors: James E
authors: JE
authors: Frampton
mesh_terms: D017327:Clinical Trials, Phase IV as Topic; D003027:Cluster Headache / Q000188:drug therapy* / Q000503:physiopathology; D016503:Drug Delivery Systems; D006801:Humans; D055104:Infusions, Subcutaneous; D008881:Migraine Disorders / Q000188:drug therapy* / Q000503:physiopathology; D009339:Needles; D058825:Serotonin 5-HT1 Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018170:Sumatriptan / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D014363:Tryptamines / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*
chemical_list: D058825:Serotonin 5-HT1 Receptor Agonists; D014363:Tryptamines; D018170:Sumatriptan