Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine

Michail Vikelis,1 Dimos D Mitsikostas,2 Alan M Rapoport31Glyfada Headache Center, Glyfada, Greece; 2Neurology Department, Athens Naval Hospital, Athens, Greece; 3The David Geffen School of Medicine at UCLA, Los Angeles, CA, USAAbstract: Migraine is a chronic, painful, and often disabling primary hea...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Vikelis M, Mitsikostas DD, Rapoport AM
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2012
Materias:
Acceso en línea:https://doaj.org/article/613f0fffd51b466fadfee1875b2c3575
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:613f0fffd51b466fadfee1875b2c3575
record_format dspace
spelling oai:doaj.org-article:613f0fffd51b466fadfee1875b2c35752021-12-02T08:50:44ZSumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine1176-63281178-2021https://doaj.org/article/613f0fffd51b466fadfee1875b2c35752012-09-01T00:00:00Zhttp://www.dovepress.com/sumatriptan-transdermal-iontophoretic-patch-np101-zelrixtrade-review-o-a11113https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Michail Vikelis,1 Dimos D Mitsikostas,2 Alan M Rapoport31Glyfada Headache Center, Glyfada, Greece; 2Neurology Department, Athens Naval Hospital, Athens, Greece; 3The David Geffen School of Medicine at UCLA, Los Angeles, CA, USAAbstract: Migraine is a chronic, painful, and often disabling primary headache disorder, typically presenting with recurrent attacks that may be accompanied by a variety of neurological, gastrointestinal, and autonomic symptoms. Gastrointestinal symptoms in association with migraine including, nausea, vomiting, and gastroparesis, affect a large proportion of migraine sufferers. These symptoms may result in delays or inconsistencies in the absorption of oral treatments. Hence, the necessity for an innovative, non-invasive, parenteral delivery formulation for quick and effective treatment of migraine attacks is evident. Iontophoresis utilizes minimal amounts of electrical potential to support the fast transfer of ionized medication transdermally and into the general circulation. Two pharmacokinetic clinical trials have shown that iontophoretic delivery of sumatriptan through the skin produces quick and reproducible therapeutic plasma concentrations. A randomized, double-blind, multicenter, phase III study demonstrated superior efficacy versus placebo and excellent tolerability, with no triptan-related adverse events. The proportion of patients that were pain-free at 2 h post-treatment was 18% for the sumatriptan patch vs 9% for placebo (P = 0.0092; number needed to treat = 11.1). Upon approval from the Food and Drug Administration and other regulatory authorities, the iontophoretic transdermal delivery of sumatriptan will be a good choice for patients experiencing poor absorption of oral medication often associated with migraine and/or for those with intolerable triptan-related adverse events.Keywords: iontophoretic patch, migraine, migraine treatment, sumatriptan, transdermal patchVikelis MMitsikostas DDRapoport AMDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2012, Iss default, Pp 429-434 (2012)
institution DOAJ
collection DOAJ
language EN
topic Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
Neurology. Diseases of the nervous system
RC346-429
spellingShingle Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
Neurology. Diseases of the nervous system
RC346-429
Vikelis M
Mitsikostas DD
Rapoport AM
Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine
description Michail Vikelis,1 Dimos D Mitsikostas,2 Alan M Rapoport31Glyfada Headache Center, Glyfada, Greece; 2Neurology Department, Athens Naval Hospital, Athens, Greece; 3The David Geffen School of Medicine at UCLA, Los Angeles, CA, USAAbstract: Migraine is a chronic, painful, and often disabling primary headache disorder, typically presenting with recurrent attacks that may be accompanied by a variety of neurological, gastrointestinal, and autonomic symptoms. Gastrointestinal symptoms in association with migraine including, nausea, vomiting, and gastroparesis, affect a large proportion of migraine sufferers. These symptoms may result in delays or inconsistencies in the absorption of oral treatments. Hence, the necessity for an innovative, non-invasive, parenteral delivery formulation for quick and effective treatment of migraine attacks is evident. Iontophoresis utilizes minimal amounts of electrical potential to support the fast transfer of ionized medication transdermally and into the general circulation. Two pharmacokinetic clinical trials have shown that iontophoretic delivery of sumatriptan through the skin produces quick and reproducible therapeutic plasma concentrations. A randomized, double-blind, multicenter, phase III study demonstrated superior efficacy versus placebo and excellent tolerability, with no triptan-related adverse events. The proportion of patients that were pain-free at 2 h post-treatment was 18% for the sumatriptan patch vs 9% for placebo (P = 0.0092; number needed to treat = 11.1). Upon approval from the Food and Drug Administration and other regulatory authorities, the iontophoretic transdermal delivery of sumatriptan will be a good choice for patients experiencing poor absorption of oral medication often associated with migraine and/or for those with intolerable triptan-related adverse events.Keywords: iontophoretic patch, migraine, migraine treatment, sumatriptan, transdermal patch
format article
author Vikelis M
Mitsikostas DD
Rapoport AM
author_facet Vikelis M
Mitsikostas DD
Rapoport AM
author_sort Vikelis M
title Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine
title_short Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine
title_full Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine
title_fullStr Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine
title_full_unstemmed Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine
title_sort sumatriptan transdermal iontophoretic patch (np101-zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine
publisher Dove Medical Press
publishDate 2012
url https://doaj.org/article/613f0fffd51b466fadfee1875b2c3575
work_keys_str_mv AT vikelism sumatriptantransdermaliontophoreticpatchnp101zelrixamptradereviewofpharmacologyclinicalefficacyandsafetyintheacutetreatmentofmigraine
AT mitsikostasdd sumatriptantransdermaliontophoreticpatchnp101zelrixamptradereviewofpharmacologyclinicalefficacyandsafetyintheacutetreatmentofmigraine
AT rapoportam sumatriptantransdermaliontophoreticpatchnp101zelrixamptradereviewofpharmacologyclinicalefficacyandsafetyintheacutetreatmentofmigraine
_version_ 1718398363835039744