Alsuma (Sumatriptan) - Summary

ALSUMA SUMMARY

Sumatriptan is a selective 5-hydroxy-tryptamine receptor subtype 1 (5-HT₁) agonist.

ALSUMA (sumatriptan injection) 6 mg/0.5 mL is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. Important Limitations

ALSUMA 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 ALSUMA, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.

ALSUMA 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 HIGHLIGHTS

Published Studies Related to Alsuma (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]
SUMMARY 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

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Clinical Trials Related to Alsuma (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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Reports of Suspected Alsuma (Sumatriptan) Side Effects

Drug Ineffective (5),  Injection Site Urticaria (4),  Injection Site Haematoma (3),  Injection Site Haemorrhage (3),  Injection Site Swelling (3),  Drug Interaction (2),  Headache (2),  Overdose (2),  Chest Pain (2),  Product Quality Issue (2), more >>