Needle‐Free Subcutaneous Sumatriptan (Sumavel™ DosePro™): Bioequivalence and Ease of Use

Brandes, Jan Lewis; Cady, Roger; Freitag, Fred; Smith, Timothy R.; Chandler, Patricia; Fox, Anthony W.; Linn, Lawrence; Farr, Stephen J.

doi:10.1111/j.1526-4610.2009.01530.x

Cited by 41 publications

(65 citation statements)

References 12 publications

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“…The following comparison of the efficacy of oral triptans and that of subcutaneous sumatriptan, available in needle-based and needle-free forms, illustrates this point. The needle-free, single-use, subcutaneous sumatriptan product delivers, via a tiny biphasic burst of pressure, a therapeutic dose in less than 100 milliseconds with no assembly required [25][26][27][28] . It was developed to provide the efficacy of subcutaneous sumatriptan without using a needle 25,26 .…”

Section: Comparison Of Triptans With Respect To Sustained Pain-free Rmentioning

confidence: 99%

Efficacy endpoints in migraine clinical trials: the importance of assessing freedom from pain

Silberstein

Newman

Marmura

et al. 2013

Current Medical Research and Opinion

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Many efficacy endpoints have been used in clinical trials of acute migraine pharmacotherapy. Headache response or headache relief (i.e., moderate/severe pain reduced to mild/no pain) at a single, specified time-point, traditionally the primary endpoint, and headache recurrence (i.e., return of pain after initial postdose relief) are inadequate. Headache relief does not provide information about pain-free response and counts a partial response as a treatment success. Headache recurrence can reflect sustained efficacy but is confounded by initial response to treatment, because ineffective drugs have low recurrence rates. The International Headache Society (IHS) guidelines state that 2 hour pain-free response and sustained pain-free response (i.e., freedom from pain with no recurrence or use of rescue or study medication 2-24 hours postdose) provide the most clinically relevant information about the efficacy of migraine pharmacotherapy. The pain-free criterion counts partial responses as failures and thus is a more rigorous test of therapeutic benefit than headache relief, and the two endpoints together incorporate the main treatment attributes that determine patient satisfaction. As an example, consider needle-free subcutaneous sumatriptan and oral triptan tablets. An open-label study of needle-free subcutaneous sumatriptan by Cady and colleagues found that 2 hour pain-free response and sustained pain-free response were 64% and 42% respectively. For oral triptan tablets, the 2001 metaanalysis by Ferrari and colleagues reported 2 hour pain-free response rates ranging from 23% to 38% and sustained pain-free response rates ranging from 11% to 26%. The measures of pain-free response 2 hours postdose and sustained pain-free response can differentiate among treatments and be used to guide therapeutic choices.

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Section: Comparison Of Triptans With Respect To Sustained Pain-free Rmentioning

confidence: 99%

Efficacy endpoints in migraine clinical trials: the importance of assessing freedom from pain

Silberstein

Newman

Marmura

et al. 2013

Current Medical Research and Opinion

View full text Add to dashboard Cite

show abstract

“…The sumatriptan transdermal patch, reviewed in this issue in detail by Pierce (page 159), is described as a medicine delivery using an iontophoretic approach that completely bypasses gastrointestinal issues in migraine and may provide some advantages in terms of reduced side effect burden. 12 For patients who are needle-averse, a needle-free device, 13 with excellent absorption characteristics, is covered by Silberstein in this issue. Similarly, a novel inhaler system is described that delivers a wellcharacterized medicine, dihydroergotamine, by a nonoral route.…”

Section: Improving Current Treatmentsmentioning

confidence: 99%

Headache

Goadsby

2010

Neurotherapeutics

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“…Ein Problem ist allerdings, dass viele Patienten Angst vor Nadeln haben und deshalb diese Applikationsform nicht verwenden. Eine amerikanische Firma (Zogenix) hat jetzt ein nadelfreies System entwickelt, mit dem Sumatriptan subkutan appliziert werden kann [28]. Im ersten Teil der Studie verwendeten 57 Patienten entweder die normale subkutane Applikationsform von Sumatriptan oder die neue nadelfreie Anwendung.…”

Section: Analgetikaunclassified

Neues zu Kopfschmerzen 2010

Diener¹,

Gaul²,

Holle³

et al. 2010

Akt Neurol

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Needle‐Free Subcutaneous Sumatriptan (Sumavel™ DosePro™): Bioequivalence and Ease of Use

Abstract: Sumavel DosePro needle-free delivery system is a new presentation of s.c. sumatriptan that delivers drug effectively, is bioequivalent to the existing needle auto-injector when used at the thigh or abdomen, and is easy to use.

Cited by 41 publications

References 12 publications

Efficacy endpoints in migraine clinical trials: the importance of assessing freedom from pain

Efficacy endpoints in migraine clinical trials: the importance of assessing freedom from pain

Headache

Neues zu Kopfschmerzen 2010

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