IMITREX SUMMARY
IMITREX®
(sumatriptan succinate)
Tablets
IMITREX Tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 receptor subtype agonist.
IMITREX Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
IMITREX Tablets are 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 Tablets have not been established for cluster headache, which is present in an older, predominantly male population.
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NEWS HIGHLIGHTSMedia Articles Related to Imitrex (Sumatriptan)
APP Pharmaceuticals Receives Approval For Sumatriptan Succinate Injection, USP
Source: Headache / Migraine News From Medical News Today [2009.10.09]
APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Sumatriptan Succinate Injection, USP, in two dosage strengths. Sumatriptan Succinate Injection is therapeutically equivalent to the reference-listed drug Imitrex®, which is marketed by the innovator GlaxoSmithKline.
Zogenix And Astellas Announce Data Published Showing The Benefits Of SUMAVEL(TM) DosePro(TM) Needle-Free Delivery System
Source: Headache / Migraine News From Medical News Today [2009.10.23]
Zogenix, Inc. ("Zogenix"), a privately held pharmaceutical company, and Astellas Pharma US, Inc. ("Astellas") announced that positive results from two clinical studies of new SUMAVEL DosePro (sumatriptan injection) needle-free delivery system will be published in the November 2009 issue of Headache. SUMAVEL DosePro, was recently approved by the FDA to treat acute migraine, with or without aura, and cluster headache.
NovaDel Article Published In Headache: The Journal Of Head And Face Pain
Source: Headache / Migraine News From Medical News Today [2009.09.03]
NovaDel Pharma Inc. (NYSE AMEX: NVD) announced that an article titled "Rapid Oral Transmucosal Absorption of Sumatriptan, and Pharmacodynamics in Acute Migraine" was published online on June 22, 2009 in the peer-reviewed journal Headache: The Journal of Head and Face Pain. NovaDel conducted two clinical trials evaluating sumatriptan administered via its oral spray drug delivery technology.
Published Studies Related to Imitrex (Sumatriptan)
Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study. [2009.08]
Two identical randomized, placebo-controlled, crossover studies were conducted to evaluate consistency of response to sumatriptan/naproxen sodium 85/500 mg (S/NS) over four attacks in adults with migraine. Patients were instructed to treat within 1 h of pain onset while pain was mild... The incidences of any adverse event and of specific adverse events were low and generally similar between S/NS and placebo.
Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. [2009.07]
OBJECTIVE: To evaluate the efficacy and tolerability of sumatriptan-naproxen during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea... CONCLUSION: Sumatriptan-naproxen provided an effective pain-free response at 2 hours, which was maintained up to 48 hours in menstrual migraineurs with dysmenorrhea. Sumatriptan-naproxen was well-tolerated and resulted in decreased rescue medication use and relief of nonpainful menstrual symptoms. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00329459 and NCT00329355 LEVEL OF EVIDENCE: I.
Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. [2009.07]
OBJECTIVE: To evaluate efficacy and tolerability of a single, fixed-dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan/naproxen sodium) vs placebo in migraineurs who had discontinued treatment with a short-acting triptan because of poor response or intolerance. BACKGROUND: Triptan monotherapy is ineffective or poorly tolerated in 1 of 3 migraineurs and in 2 of 5 migraine attacks. In April, 2008, the Food and Drug Administration approved the combination therapy sumatriptan/naproxen sodium, developed specifically to target multiple migraine mechanisms. This combination product offers an alternative migraine therapy for patients who have reported poor response or intolerance to short-acting triptans... CONCLUSION: In migraineurs who reported poor response to a short-acting triptan, sumatriptan/naproxen sodium was generally well tolerated and significantly more effective than placebo in conferring initial, intermediate, and sustained efficacy for pain and migraine-associated symptoms of photophobia and phonophobia.
Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine. [2008.07.08]
BACKGROUND: Research suggests treating a migraine at the first sign of pain increases the likelihood of the best clinical outcome. OBJECTIVE: To investigate the efficacy and tolerability of a fixed-dose, single-tablet formulation of sumatriptan 85 mg, formulated with RT Technology, and naproxen sodium 500 mg (sumatriptan/naproxen) as early intervention acute therapy for migraine... CONCLUSION: The fixed-dose single-tablet formulation of sumatriptan/naproxen was effective and well tolerated in an early intervention paradigm for the acute treatment of migraine, including traditional and nontraditional symptoms.
Activation of the cortical pain network by soft tactile stimulation after injection of sumatriptan. [2007.12.15]
The anti-migraine drug sumatriptan often induces unpleasant somatosensory side effects, including a dislike of being touched. With a double-blind cross-over design, we studied the effects of sumatriptan and saline on perception (visual analogue scale) and cortical processing (functional magnetic resonance imaging) of tactile stimulation in healthy subjects...
Clinical Trials Related to Imitrex (Sumatriptan)
Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan
succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1
x 100 mg) dose administered under fed conditions.
Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan
succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1
x 100 mg) dose administration under fasting conditions.
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department [Completed]
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR
imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is
improvement in pain scales between the groups.
A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System [Completed]
Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex® [Completed]
The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently
approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and
to assess the bioavailability relative to the 6 mg subcutaneous injection.
The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 18 ratings/reviews, Imitrex has an overall score of 8.89. The effectiveness score is 9.33 and the side effect score is 8.22. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Imitrex review by 55 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Migraine headaches |
| Dosage & duration: | | 100 mg taken as needed for the period of I have been taking as needed for 6 years |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Complete relief from pain with one 100 mg tablet. Alleviated the sensitivity to light, noise and nausea. Symptoms would abate in one to two hours. |
| Side effects: | | A little "fuzzy headed" until it took effect. |
| Comments: | | This is taken as needed. It works best to take at the onset of the migraine and not to wait to see if will go away. |
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| | Imitrex review by 59 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Migraine Headaches |
| Dosage & duration: | | 50 miligrams (dosage frequency: as needed, as often as 10-16 per a month) for the period of 1994 to present |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Within 30 minutes for injections to 2 hours for caplets I was pain free and functional.
I had gone camping and run out of Imitrex. I was in pain for about 14 hours when I was taken to a little emergency clinic. They gave me an injection of 50 miligrams and in about 15 minutes I was pain free and feeling normal. |
| Side effects: | | Sometimes a little queasiness if taken on an empty stomach. Sometimes a little fatigue and a feeling of slight slowness. |
| Comments: | | My insurance only covers 9 pills every 28 days, so my physician prescribes 100 miligram caplets and I cut them in half to give more dosages. The caplets work well if the migraine is caught early. I most often wake up with the migraine starting and will take my pill and lie back down with a cold cloth or ice pack for 30 minutes to 2 hours depending on how advanced the pain is.
If I catch it really early the pain stops progressing and I feel well with in 30 minutes to an hour.
If the maigraine has progressed too far the caplets don't work and I use a self injection of the 50 miligram dosage which works within 30 to 60 minutes without much side effect.
If I take the Imitrex by mistake for a headache that is not a migraine I get queasy and tight in the stomach and feel hung over. |
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| | Imitrex review by 39 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | migraines |
| Dosage & duration: | | 1 tablet (100mg) taken as needed for the period of 3 times |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I initially switched over from Axert since my insurance covers more of the Imitrex prescription. Imitrex just isn't right for me. I experienced almost all of the side effects such as flushing, sensations of tingling/prickling, weakness, drowsiness, dizziness, and fast/pounding heartbeat. On top of that the packaging is just HORRIBLE! It comes 9 to a package. The packaging is a tri-fold "booklet" that is very rigid and has individual blisters for each tablet. It's about 6 1/2 by 3 1/2 inches, folded. I like to have migraine meds on me at all times so I ended up cutting the tablets out of the booklet so they would fit in my wallet or purse. Definitely going back to Axert! |
| Side effects: | | flushing, tingling, prickling, weakness, drowsiness, dizziness and pounding heartbeat. |
| Comments: | | Take 1 tablet by mouth. Max 2 tabs per 24 hours. |
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Page last updated: 2009-10-23
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