Pharmacokinetics & Drug Delivery | Neuropharmacology & Psychopharmacology | Headache | Methods for Diagnostic & Therapeutic Studies
Long term safety of the sumatriptan iontophoretic transdermal patch, NP101, for acute migraine: a 12 month, repeat use, open label study
Timothy Smith, Mark Pierce*, Kerri Wilks, Carol O'Neill, Steven Silberstein
*Corresponding author: Mark Pierce
Medical Affairs, NuPathe Inc, Conshohocken, PA, USA
F1000Posters 2012, 3: 668 (poster) [English]
Poster [3.48 MB]
Presented at
54th American Headache Society Annual Meeting 2012,
21 - 24 Jun 2012, P13
Oral triptans are often the most effective treatment for acute migraine, but may produce unsatisfactory results for patients with migraine-related nausea and vomiting, or for those who delay or avoid treatment. Moreover, gastroparesis may adversely impact drug absorption and pharmacokinetics, resulting in delayed, inconsistent or incomplete relief. NP101 is a noninvasive, transdermal patch that uses a low-level electrical current to drive ionized sumatriptan into the bloodstream at controlled rates, resulting in predictable pharmacokinetics and clinical efficacy. We evaluated the safety of NP101 for acute migraine over 12 months.
NP101 was safe and well tolerated in a repeat use study involving 479 patients applying nearly 8000 NP101 patches. Rescue medication was used infrequently, and the adverse events were similar to those in previous NP101 studies.
Authors Timothy Smith, Kerri Wilks and Steven Silberstein served as clinical investigators and scientific advisers for NuPathe Inc. Corresponding author Mark Pierce and author Carol O' Neill are paid employees of NuPathe Inc.
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