SUMATRIPTAN SUMMARY
Sumatriptan succinate tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 receptor subtype agonist.
Sumatriptan succinate tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
Sumatriptan succinate 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 sumatriptan succinate 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 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 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 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.
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.
A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs [Completed]
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled
with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections
over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.
A Study on the Usability of the Needle-Free Intraject® System in Adult Patients During Acute Migraine Attack [Completed]
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled
with 6mg Sumatriptan to be used by patients to treat acute migraine treatment. Study
participation will last one month and include 2 doctor visits and 2-4 phone calls.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Sumatriptan has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Sumatriptan review by 43 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | maigrains |
| Dosage & duration: | | 1 (dosage frequency: once a month) for the period of one week ago |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | ceasation of maigrain. The drug provides relive within half an hour of having been administered and prevents further symptomps |
| Side effects: | | there are no aparent side effects from the use of this drug |
| Comments: | | 1 pill to be taken with onset of attack. If the attack has already started and the treatment cannot be reached within the first 5 hours of the attack, a further dose of the drug may be required |
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Page last updated: 2009-10-23
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