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...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2012-09-01
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| Series: | Neuropsychiatric Disease and Treatment |
| Online Access: | http://www.dovepress.com/sumatriptan-transdermal-iontophoretic-patch-np101-zelrixtrade-review-o-a11113 |
| _version_ | 1818997224991883264 |
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| author | Vikelis M Mitsikostas DD Rapoport AM |
| author_facet | Vikelis M Mitsikostas DD Rapoport AM |
| author_sort | Vikelis M |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-12-20T21:42:15Z |
| format | Article |
| id | doaj.art-613f0fffd51b466fadfee1875b2c3575 |
| institution | Directory Open Access Journal |
| issn | 1176-6328 1178-2021 |
| language | English |
| last_indexed | 2024-12-20T21:42:15Z |
| publishDate | 2012-09-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Neuropsychiatric Disease and Treatment |
| spelling | doaj.art-613f0fffd51b466fadfee1875b2c35752022-12-21T19:25:45ZengDove Medical PressNeuropsychiatric Disease and Treatment1176-63281178-20212012-09-012012default429434Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraineVikelis MMitsikostas DDRapoport AMMichail 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 patchhttp://www.dovepress.com/sumatriptan-transdermal-iontophoretic-patch-np101-zelrixtrade-review-o-a11113 |
| spellingShingle | 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 Neuropsychiatric Disease and Treatment |
| title | 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_short | 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 amp trade review of pharmacology clinical efficacy and safety in the acute treatment of migraine |
| url | http://www.dovepress.com/sumatriptan-transdermal-iontophoretic-patch-np101-zelrixtrade-review-o-a11113 |
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