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

@article{Brandes2009NeedleFreeSS,
  title={Needle‐Free Subcutaneous Sumatriptan (Sumavel{\texttrademark} DosePro{\texttrademark}): Bioequivalence and Ease of Use},
  author={Jan Lewis Brandes and Roger K. Cady and Frederick G Freitag and Timothy R. Smith and Patricia Chandler and Anthony W Fox and Lawrence Linn and Stephen J. Farr},
  journal={Headache: The Journal of Head and Face Pain},
  year={2009},
  volume={49}
}
Background.— Subcutaneous (s.c.) injection of sumatriptan is currently associated with needle aversion in some patients, and sharps disposal issues. 
Needle-Free Subcutaneous Sumatriptan
TLDR
The use of needle-free subcutaneous sumatriptan was associated with a significant improvement in treatment satisfaction in these patients who were less than ‘very satisfied’ with their usual symptomatic therapy, and was generally well tolerated in the phase IV study.
Sumatriptan needle-free subcutaneous (Sumavel® DosePro™) approved for the acute treatment of migraine, with or without aura, and cluster headaches
  • F. Freitag
  • Medicine
    Expert review of neurotherapeutics
  • 2011
TLDR
A new method of delivery for this agent, Sumavel® DosePro™, eliminates the needle and disposal issues coupled with an improved ease of use of drug delivery and acceptable tolerability for patients in clinical trials.
A Review of Needle‐Free Sumatriptan Injection for Rapid Control of Migraine
TLDR
Clinical trials have shown that the needle‐free sumatriptan injection system (Sumavel DosePro) is bioequivalent to needle‐based injection systems, easy to use, and capable of providing rapid and effective symptom relief for many migraine episodes.
Needle-free subcutaneous sumatriptan for triptan users requiring a change in migraine therapy: efficacy and impact on patient-rated functionality, satisfaction, and confidence
TLDR
With SDP, triptan users requiring a change in therapy experienced increased efficacy, satisfaction with therapy, and confidence in treatment without deterioration in tolerability.
Subcutaneous delivery of sumatriptan in the treatment of migraine and primary headache
TLDR
Subcutaneous sumatriptan is a good first-line agent for the treatment of pain from acute migraine headaches and primary headaches and its use should be limited to those without known cerebrovascular disease and limited in those with known cardiovascular risk factors and unknown disease status.
Injeção sem agulhas: aplicações médicas e perspectivas futuras
TLDR
This review aims at addressing the advantages of needle-free systems in therapy by discussing their mechanisms of action, the advantages and obstacles to their use, differences between the types of injectors, and their applications and future perspectives.
Two-layered dissolving microneedles for percutaneous delivery of sumatriptan in rats
TLDR
The usefulness of DM as a noninvaisive transdermal delivery system of sumatriptan to migraine therapy is suggested and good dose dependency was observed on Cmax and AUC.
Pediatric Headache: A Clinical Review
TLDR
The epidemiology, classification, and approach to the diagnosis and treatment of episodic and chronic migraine in children and the future of pediatric headache are described.
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References

SHOWING 1-10 OF 15 REFERENCES
Resolution of Concentration–Response Differences in Onset of Effect Between Subcutaneous and Oral Sumatriptan
TLDR
Whether the concentration–response relationships for onset of effect of oral and subcutaneous sumatriptan differ, and if so, then to explore whether a single model for the onset ofeffect can nonetheless be found for multiple dose sizes and both routes of administration.
Onset of Effect of 5‐HT1B/1D Agonists: A Model With Pharmacokinetic Validation
Objective.—To quantitate onset of effect of all formulations of sumatriptan, and to investigate whether this is related to rate, not extent, of drug absorption.
Sumatriptan 6 mg subcutaneous as an effective migraine treatment in patients with cutaneous allodynia who historically fail to respond to oral triptans
TLDR
SC 6 mg sumatriptan proved to be effective despite the occurrence of allodynia in a group of patients, who historically had failed to respond to oral triptan medications, which suggests that the window of opportunity to treat allodynic patients with injectable triptans may be longer than with oral triPTans.
Safety profile of the triptans
TLDR
The triptans are 5-HT1B/1D agonists used as migraine and cluster-specific agents, and although postmarketing studies have stimulated much debate of triptan strengths and weaknesses, their overall safety profile appears excellent.
Treatment of acute migraine with subcutaneous sumatriptan.
TLDR
Sumatriptan is effective and well tolerated in patients with acute migraine and reduced nausea and photophobia significantly better than placebo.
The Effects of System Parameters on In Vivo Injection Performance of a Needle-Free Injector in Human Volunteers
TLDR
Both device-related factors and subject variables interact to mediate in vivo performance of a needle-free injector.
Infrequent or Non-Response to Oral Sumatriptan does not Predict Response to Other Triptans—Review of Four Trials
  • C. Dahlöf
  • Medicine
    Cephalalgia : an international journal of headache
  • 2006
TLDR
It can be concluded that migraine patients who respond infrequently to sumatriptan should be switched to a different triPTan, as lack of response to one triptan does not predict likelihood of responsiveness to another.
Interindividual variability of oral sumatriptan pharmacokinetics and of clinical response in migraine patients
TLDR
The slow rate and low extent of absorption of the drug during the first 2 h after dosing observed in patients of group B could explain their unsatisfactory response to oral sumatriptan.
Efficacy of subcutaneous sumatriptan in repeated episodes of migraine
TLDR
Patients' perceptions of sumatriptan were consistent with clinical data demonstrating the drug's high degree of efficacy and tolerability, and the frequency and severity of adverse events did not change with repeated administration.
Sumatriptan-naproxen for acute treatment of migraine: a randomized trial.
TLDR
Sumatriptan, 85 mg, plus naproxen sodium, 500 mg, as a single tablet for acute treatment of migraine resulted in more favorable clinical benefits compared with either monotherapy, with an acceptable and well-tolerated adverse effect profile.
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