A Sumatriptan Iontophoretic Transdermal System for the Acute Treatment of Migraine

Authors

  • Jerome Goldstein MD,

    Corresponding author
    1. From the San Francisco Clinical Research Center, San Francisco, CA, USA (J. Goldstein); Mercy Health Research, Mercy Clinic Headache Center, St. Louis, MO, USA (T.R. Smith); Brighton Research Group, LLC, Virginia Beach, VA, USA (N. Pugach); The Griesser Group, West Conshohocken, PA, USA (J. Griesser); NuPathe Inc., Conshohocken, PA, USA (T. Sebree and M. Pierce).
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  • Timothy R. Smith MD, RPh, FACP,

    1. From the San Francisco Clinical Research Center, San Francisco, CA, USA (J. Goldstein); Mercy Health Research, Mercy Clinic Headache Center, St. Louis, MO, USA (T.R. Smith); Brighton Research Group, LLC, Virginia Beach, VA, USA (N. Pugach); The Griesser Group, West Conshohocken, PA, USA (J. Griesser); NuPathe Inc., Conshohocken, PA, USA (T. Sebree and M. Pierce).
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  • Neil Pugach MD,

    1. From the San Francisco Clinical Research Center, San Francisco, CA, USA (J. Goldstein); Mercy Health Research, Mercy Clinic Headache Center, St. Louis, MO, USA (T.R. Smith); Brighton Research Group, LLC, Virginia Beach, VA, USA (N. Pugach); The Griesser Group, West Conshohocken, PA, USA (J. Griesser); NuPathe Inc., Conshohocken, PA, USA (T. Sebree and M. Pierce).
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    • Dr. Pugach is no longer affiliated with Brighton Research Group, LLC.

  • Jim Griesser MA,

    1. From the San Francisco Clinical Research Center, San Francisco, CA, USA (J. Goldstein); Mercy Health Research, Mercy Clinic Headache Center, St. Louis, MO, USA (T.R. Smith); Brighton Research Group, LLC, Virginia Beach, VA, USA (N. Pugach); The Griesser Group, West Conshohocken, PA, USA (J. Griesser); NuPathe Inc., Conshohocken, PA, USA (T. Sebree and M. Pierce).
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  • Terri Sebree BS,

    1. From the San Francisco Clinical Research Center, San Francisco, CA, USA (J. Goldstein); Mercy Health Research, Mercy Clinic Headache Center, St. Louis, MO, USA (T.R. Smith); Brighton Research Group, LLC, Virginia Beach, VA, USA (N. Pugach); The Griesser Group, West Conshohocken, PA, USA (J. Griesser); NuPathe Inc., Conshohocken, PA, USA (T. Sebree and M. Pierce).
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  • Mark Pierce MD, PhD

    1. From the San Francisco Clinical Research Center, San Francisco, CA, USA (J. Goldstein); Mercy Health Research, Mercy Clinic Headache Center, St. Louis, MO, USA (T.R. Smith); Brighton Research Group, LLC, Virginia Beach, VA, USA (N. Pugach); The Griesser Group, West Conshohocken, PA, USA (J. Griesser); NuPathe Inc., Conshohocken, PA, USA (T. Sebree and M. Pierce).
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  • Author statement of responsibility: Dr. Goldstein takes full responsibility for the data, the analyses and interpretation, and the conduct of the research. Dr. Goldstein had full access to all of the data, and has the right to publish any and all data separate and apart from any sponsor.

  • ClinicalTrials.gov identifier: NCT00724815.

  • Study funding: Supported by NuPathe Inc.

  • Author contributions: Dr. Goldstein contributed to the design of study, execution of study, and critical review of the manuscript. Dr. Smith contributed to the execution of study and critical review of the manuscript. Dr. Pugach contributed to the execution of study and critical review of the manuscript. Mr. Griesser contributed to the design of study, statistical analysis and data review, and critical review of the manuscript. Ms. Sebree and Dr. Pierce contributed to the design of study, execution of study, and critical review of the manuscript.

  • Study sponsor: NuPathe Inc., Conshohocken, PA.

  • Conflict of Interest: Drs. Goldstein, Smith, and Pugash have served as clinical investigators and advisors to NuPathe Inc. Mr. Griesser is a biostatistician at The Griesser Group. Ms. Sebree and Dr. Pierce are employed by NuPathe Inc.

J. Goldstein, San Francisco Clinical Research Center, 909 Hyde Street, Suite 322, San Francisco, CA 94109, USA, email: sfhaclin@aol.com

Abstract

Objective.— Gastrointestinal symptoms, such as nausea and vomiting, occur almost universally at one time or another in patients during a migraine attack. One third of patients who experience migraine-related nausea report that this symptom interferes with their ability to take oral medications. The sumatriptan iontophoretic transdermal system (NuPathe Inc., Conshohocken, PA, USA) uses proprietary technology to circumvent the gastrointestinal tract while delivering triptan therapy. This phase III randomized, double-blind, placebo-controlled trial evaluated the efficacy and tolerability of this system for the acute treatment of migraine.

Methods.— Patients were randomized to treat a single moderate-to-severe migraine attack with the sumatriptan iontophoretic transdermal system or placebo. The primary end point was the proportion of patients who were headache pain-free 2 hours after patch activation. Other end points included the proportions of patients who reported headache pain relief, and freedom from nausea, photophobia, and phonophobia; rescue medication use; and tolerability.

Results.— Four hundred sixty-nine patients were treated. Significantly more patients treated with the sumatriptan iontophoretic transdermal system compared with placebo experienced freedom from headache pain, nausea, photophobia, and phonophobia 2 hours after patch activation, experienced rapid and sustained headache pain relief, and used less rescue medication. Treatment-emergent adverse events were reported by 50% and 44% of patients treated with the sumatriptan iontophoretic transdermal system and placebo, respectively. Most events were transient mild-to-moderate application-site reactions.

Conclusions.— The sumatriptan iontophoretic transdermal system is effective and well tolerated, and may be particularly useful in patients with migraine-related gastrointestinal symptoms such as nausea.

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