NEWS HIGHLIGHTSMedia Articles Related to Imitrex Nasal (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 Nasal (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 Nasal (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.
|
