SUMMARY
Sumatriptan, the active component of Sumavel DosePro, is a selective 5-hydroxy-tryptamine receptor subtype 1 (5-HT1) agonist.
Sumavel DosePro (sumatriptan injection) is indicated for the following:
1.1 Acute Treatment of Migraine Attacks and Cluster Headache
Sumavel DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
1.2 Important Limitations
Sumavel DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. Care should be taken to exclude other potentially serious neurologic conditions before treating headache in patients not previously diagnosed with migraine or cluster headache or who experience a headache that is atypical for them.
For a given attack, if a patient does not respond to the first dose of Sumavel DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.
Sumavel DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. [see Contraindications ]
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NEWS HIGHLIGHTSMedia Articles Related to Sumavel Dosepro (Sumatriptan)
Skin Patch For Migraines Receives FDA Approval
Source: Headache / Migraine News From Medical News Today [2013.01.20]
The FDA has approved Zecuity (sumatriptan iontophoretic transdermal system) for the treatment of acute migraine in adults with or without aura. Zecuity is a battery-powered skin patch that delivers sumatriptan through the patient's skin - it is a single-use medication. Sumatriptan is the most extensively prescribed migraine drug. According to NuPathe Inc...
Published Studies Related to Sumavel Dosepro (Sumatriptan)
A sumatriptan iontophoretic transdermal system for the acute treatment of
migraine. [2012]
treatment of migraine... CONCLUSIONS: The sumatriptan iontophoretic transdermal system is effective and
Sumatriptan (subcutaneous route of administration) for acute migraine attacks in
adults. [2012]
CONCLUSIONS: Subcutaneous sumatriptan is effective as an abortive
Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. [2011.05]
OBJECTIVE: To evaluate the impact of a sumatriptan/naproxen sodium combination tablet on patient satisfaction, productivity, and functional disability in menstrual migraine treated during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea. BACKGROUND: Menstrual migraineurs with dysmenorrhea represent a unique patient population not previously studied. When health outcomes end points are analyzed alongside traditional efficacy end points in migraine studies, a more comprehensive and robust understanding of the many factors that may influence patients' choice of and adherence to pharmacological treatments for migraine is observed... CONCLUSION: A fixed-dose combination tablet containing sumatriptan and naproxen sodium significantly improved patient satisfaction, productivity, and restoration of normal functioning in menstrual migraineurs with dysmenorrhea. (c) 2011 American Headache Society.
Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. [2011.05]
OBJECTIVE: The study was carried out to assess the efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treating acute migraine in patients who are non-responders to sumatriptan. BACKGROUND: Many migraineurs report dissatisfaction with sumatriptan efficacy. It is unclear whether sumatriptan 100 mg non-responders will respond to other triptans... CONCLUSION: Rizatriptan 10-mg ODT was superior to placebo at providing two-hour pain relief and two-hour pain freedom in the treatment of acute migraine in those who do not respond to sumatriptan 100 mg. Rizatriptan was generally well tolerated in this population.
Serotonin function in pathological gambling: blunted growth hormone response to sumatriptan. [2010.12]
Pathological gambling is a disruptive behaviour and an important public health concern that is classified as an impulse control disorder, and is also conceptualized as a prototype of 'behavioural addiction'. Its phenomenology cannot be reduced to a single neurobiological dysfunction; instead, it has been conceived as a complex chain of events in which the serotonergic system (5-HT) has often been suggested as one of the most prominent involved...
Clinical Trials Related to Sumavel Dosepro (Sumatriptan)
A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System [Completed]
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan [Completed]
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg
kit product for the treatment of migraine or cluster headache attacks in clinical settings,
to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness)
and rate of successful self-injection.
Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without [Recruiting]
This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally
(through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with
migraine headaches in 30 minutes after use.
Sumatriptan and Naratriptan Pregnancy Registry [Recruiting]
Anti-migraine drugs, including triptans, are not indicated for use in pregnancy. However,
the peak prevalence of migraine is in women of childbearing age. This, coupled with the
sporadic nature of migraine attacks and high rates of unplanned pregnancies, makes
unintentional exposure to anti-migraine medications during pregnancy likely. Prior to an
anti-migraine medication being marketed there are few data available on drug safety in
pregnancy: data from animal models may not translate directly to humans and pregnant women
are routinely excluded from clinical trials. The Sumatriptan Pregnancy Registry was
established by GlaxoSmithKline (GSK) in 1996 to monitor the safety of sumatriptan during
pregnancy. It was combined with the Naratriptan Pregnancy Registry in 2001 and data
collection on the sumatriptan-naproxen combination (Treximet) began in 2008.
A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents [Recruiting]
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