IMITREX NASAL SUMMARY
IMITREX (sumatriptan) Nasal Spray contains sumatriptan, a selective 5-hydroxytryptamine1 receptor subtype agonist.
IMITREX Nasal Spray is indicated for the acute treatment of migraine attacks with or without aura in adults.
IMITREX Nasal Spray is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of IMITREX Nasal Spray have not been established for cluster headache, which is present in an older, predominantly male population.
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NEWS HIGHLIGHTS
Published Studies Related to Imitrex Nasal (Sumatriptan)
Reduced efficacy of sumatriptan in migraine with aura vs without aura. [2015] migraine with aura compared with migraine without aura... CONCLUSION: This post hoc analysis of pooled data from multiple randomized trials
Sumatriptan iontophoretic transdermal system for the acute treatment of migraine. [2014] SUMMARYÂ We will describe the pharmacokinetic profile, clinical efficacy and
safety data of the sumatriptan iontophoretic transdermal system (Zecuity®,
NuPathe Inc., PA, USA), recently approved for the acute treatment of migraine
with or without aura in adults, by the US FDA.This sumatriptan transdermal system may be a good choice for migraineurs with
severe nausea or vomiting, those with intolerable triptan-related adverse events
and/or those not responding optimally to oral medications.
Sumatriptan plus naproxen for acute migraine attacks in adults. [2013] CONCLUSIONS: Combination treatment was effective in the acute treatment
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
Clinical Trials Related to Imitrex Nasal (Sumatriptan)
A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period [Completed]
The purpose of this study is to test the effect on blood pressure of sumatriptan and
naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets
containing only naproxen sodium when these drugs are taken to treat migraine headaches that
occur during a 6-month period.
Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX� in Healthy Subjects [Completed]
The purpose of this study is:
- To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg
OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX®
(sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in
healthy subjects.
- To estimate the relative bioavailability of single-dose intranasal administration of 20
mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX®
(sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan)
Subcutaneous Injection, in healthy subjects.
The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache [Recruiting]
To develop a pragmatic migraine model the investigators will induce headache in healthy
volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor
(cilostazol). If the headache responds to sumatriptan, the model can be used to test new
drug candidates.
The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache [Recruiting]
To develop a pragmatic migraine model the investigators will induce headache in healthy
volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide
(NO) donor. If the headache responds to sumatriptan, the model can be used to test new drug
candidates.
Sumatriptan and Naratriptan Pregnancy Registry [Completed]
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.
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