Trial reportPharmaceutical research2007
A unique iontophoretic patch for optimal transdermal delivery of sumatriptan.
Trial report in Pharmaceutical research, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 49 citations in OpenAlex.
- New strategies for the treatment and prevention of primary headache disorders.Nature reviews. Neurology · 2016Review
- Cutaneous Adverse Effects of Neurologic Medications.CNS drugs · 2016Review
- The iontophoretic transdermal system formulation of sumatriptan as a new option in the acute treatment of migraine: a perspective.Therapeutic advances in neurological disorders · 2015Review
- New treatments for headache.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2014Review
- Trials and tribulations of skin iontophoresis in therapeutics.British journal of clinical pharmacology · 2014Review
- The pipeline in headache therapy.CNS drugs · 2013Review
- Sumatriptan iontophoretic transdermal system: a review of its use in patients with acute migraine.Drugs · 2013Review
- Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine.Neuropsychiatric disease and treatment · 2012Article
- Preparation and evaluation of tubular micelles of pluronic lecithin organogel for transdermal delivery of sumatriptan.AAPS PharmSciTech · 2010Article
- Magnetophoresis for enhancing transdermal drug delivery: Mechanistic studies and patch design.Journal of controlled release : official journal of the Controlled Release Society · 2010Article
- Transdermal delivery of sumatriptan for the treatment of acute migraine.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2010Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeMigraines affect approximately 10% of the adult population worldwide. The purpose of this study was to assess the pharmacokinetic and safety profile of a novel iontophoretic sumatriptan delivery system, NP101, which uses an electrical current to propel sumatriptan across intact skin and into underlying tissue. Four unique prototype iontophoretic sumatriptan patch conditions were compared to a 6 mg subcutaneous injection and an oral 50 mg tablet of sumatriptan succinate. MATERIALS AND
methodsThis was a randomized, single-center, single-dose, six-period Phase I study.
resultsPatches were well tolerated with fewer adverse events than the subcutaneous injection. Adverse events that were more prevalent for NP101 than other formulations included localized sensations and reactions at the patch site. A linear relationship was observed between total applied current and sumatriptan delivery. Patches delivering 6 and 12 mA per h yielded favorable sumatriptan systemic profiles, delivering drug at a rate that maintained plasma levels above the target level (> or = 10 ng/ml) for greater than 7 h.
conclusionsThis study met the initial objective to define the dose-current relationship in humans as well as delimiting specific current and current density targets for a well tolerated patch design that can deliver therapeutic drug levels for longer periods than currently possible.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.