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TEV-48125

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https://www.readbyqxmd.com/read/28972120/fremanezumab-a-humanized-monoclonal-anti-cgrp-antibody-inhibits-thinly-myelinated-a%C3%AE-but-not-unmyelinated-c-meningeal-nociceptors
#1
Agustin Melo-Carrillo, Andrew M Strassman, Rony-Reuven Nir, Aaron J Schain, Rodrigo Noseda, Jennifer Stratton, Rami Burstein
Calcitonin gene-related peptide (CGRP), the most abundant neuropeptide in primary afferent sensory neurons, is strongly implicated in the pathophysiology of migraine headache, but its role in migraine is still equivocal. As a new approach to migraine treatment, humanized anti-CGRP monoclonal antibodies (CGRP-mAbs) were developed to reduce the availability of CGRP, and were found effective in reducing the frequency of chronic and episodic migraine. We recently tested the effect of fremanezumab (TEV-48125), a CGRP-mAb, on the activity of second-order trigeminovascular dorsal horn neurons that receive peripheral input from the cranial dura, and found a selective inhibition of high-threshold but not wide-dynamic range class of neurons...
November 1, 2017: Journal of Neuroscience: the Official Journal of the Society for Neuroscience
https://www.readbyqxmd.com/read/28862758/fremanezumab-as-add-on-treatment-for-patients-treated-with-other-migraine-preventive-medicines
#2
Joshua M Cohen, David W Dodick, Ronghua Yang, Lawrence C Newman, Thomas Li, Ernesto Aycardi, Marcelo E Bigal
BACKGROUND: Fremanezumab (formerly TEV-48125) is a monoclonal antibody directed against calcitonin-gene-related peptide (CGRP), a validated target for migraine preventive therapy. In two previous phase 2 studies, fremanezumab administered once every 28 days for 12 weeks was found to be effective and safe as a preventive treatment for patients suffering from episodic migraine (EM) and chronic migraine (CM). OBJECTIVE: To evaluate the efficacy and safety of fremanezumab as an add-on preventive therapy in individuals with EM and CM who are on stable doses of preventive migraine medications...
October 2017: Headache
https://www.readbyqxmd.com/read/28644160/calcitonin-gene-related-peptide-targeted-therapies-for-migraine-and-cluster-headache-a-review
#3
Nathaniel M Schuster, Alan M Rapoport
Calcitonin gene-related peptide (CGRP) is a signaling neuropeptide released from activated trigeminal sensory afferents in headache and facial pain disorders. There are a handful of CGRP-targeted therapies currently in phase 3 studies for migraine acute treatment or prevention. Currently, 4 monoclonal antibodies targeting either the CGRP ligand or receptor are being studied for migraine prevention: ALD403 (eptinezumab), AMG 334 (erenumab), LY2951742 (galcanezumab), and TEV-48125 (fremanezumab). Meanwhile, 1 small-molecule CGRP receptor antagonist (ubrogepant, MK-1602) is currently in phase 3 studies for the acute treatment of migraine...
July 2017: Clinical Neuropharmacology
https://www.readbyqxmd.com/read/28642283/selective-inhibition-of-trigeminovascular-neurons-by-fremanezumab-a-humanized-monoclonal-anti-cgrp-antibody
#4
Agustin Melo-Carrillo, Rodrigo Noseda, Rony Nir, Aaron J Schain, Jennifer Stratton, Andrew M Strassman, Rami Burstein
A large body of evidence supports an important role for calcitonin gene-related peptide (CGRP) in migraine pathophysiology. This evidence gave rise to a global effort to develop a new generation of therapeutics that inhibit the interaction of CGRP with its receptor in migraineurs. Recently, a new class of such drugs, humanized anti-CGRP monoclonal antibodies (CGRP-mAbs), were found to be effective in reducing the frequency of migraine. The purpose of this study was to better understand how the CGRP-mAb fremanezumab (TEV-48125) modulates meningeal sensory pathways...
July 26, 2017: Journal of Neuroscience: the Official Journal of the Society for Neuroscience
https://www.readbyqxmd.com/read/28129635/calcitonin-gene-related-peptide-monoclonal-antibody-for-preventive-treatment-of-episodic-migraine-a-meta-analysis
#5
REVIEW
Peiwei Hong, Xintong Wu, Yao Liu
Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) have shown promise in the preventive treatment of migraine. Therefore, we performed a meta-analysis to evaluate the efficacy and safety of CGRP mAbs for preventive treatment of migraine. Database including Ovid-SP, Cochrane Library, Pubmed and Web of Science (ISI) were systematically searched up to April 2, 2016 for randomized controlled trials(RCTs) which were dealing with the efficacy and safety of CGRP mAbs for preventive treatment of episodic migraine...
March 2017: Clinical Neurology and Neurosurgery
https://www.readbyqxmd.com/read/27339365/anti-cgrp-monoclonal-antibodies-in-migraine-current-perspectives
#6
REVIEW
Maria Adele Giamberardino, Giannapia Affaitati, Martina Curto, Andrea Negro, Raffaele Costantini, Paolo Martelletti
Migraine is a highly disabling neurological pain disorder in which management is frequently problematic. Most abortive and preventative treatments employed are classically non-specific, and their efficacy and safety and tolerability are often unsatisfactory. Mechanism-based therapies are, therefore, needed. Calcitonin gene-related peptide (CGRP) is recognized as crucial in the pathophysiology of migraine, and new compounds that target the peptide have been increasingly explored in recent years. First tested were CGRP receptor antagonists; they proved effective in acute migraine treatment in several trials, but were discontinued due to liver toxicity in long-term administration...
December 2016: Internal and Emergency Medicine
https://www.readbyqxmd.com/read/27281531/tev-48125-for-the-preventive-treatment-of-chronic-migraine-efficacy-at-early-time-points
#7
RANDOMIZED CONTROLLED TRIAL
Marcelo E Bigal, David W Dodick, Abouch V Krymchantowski, Juliana H VanderPluym, Stewart J Tepper, Ernesto Aycardi, Pippa S Loupe, Yuju Ma, Peter J Goadsby
OBJECTIVE: To evaluate the onset of efficacy of TEV-48125, a monoclonal antibody against calcitonin gene-related peptide, recently shown to be effective for the preventive treatment of chronic migraine (CM) and high-frequency episodic migraine. METHODS: A randomized placebo-controlled study tested once-monthly injections of TEV-48125 675/225 mg or 900 mg vs placebo. Headache information was captured daily using an electronic headache diary. The primary endpoint was change from baseline in the number of headache hours in month 3...
July 5, 2016: Neurology
https://www.readbyqxmd.com/read/26555040/new-players-in-the-preventive-treatment-of-migraine
#8
REVIEW
Dimos D Mitsikostas, Alan M Rapoport
Migraine is a common, chronic disorder of the brain causing much disability, as well as personal, familial and societal impact. Several oral preventive agents are available in different countries for the prevention of migraine, but none have performed better than 50% improvement in 50% of patients in a clinical trial. Additionally, each has various possible adverse events making their tolerability less than optimal. Recently, three monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) ligand (LY2951742, ALD403 and TEV-48125) and one targeting the CGRP receptor (AMG 334) have completed phase 2 trials, and the results have been reported...
2015: BMC Medicine
https://www.readbyqxmd.com/read/26432182/safety-tolerability-and-efficacy-of-tev-48125-for-preventive-treatment-of-high-frequency-episodic-migraine-a-multicentre-randomised-double-blind-placebo-controlled-phase-2b-study
#9
RANDOMIZED CONTROLLED TRIAL
Marcelo E Bigal, David W Dodick, Alan M Rapoport, Stephen D Silberstein, Yuju Ma, Ronghua Yang, Pippa S Loupe, Rami Burstein, Lawrence C Newman, Richard B Lipton
BACKGROUND: Calcitonin gene-related peptide (CGRP) is a validated target for the treatment of episodic migraine. Here we assess the safety, tolerability, and efficacy of TEV-48125, a monoclonal anti-CGRP antibody, in the preventive treatment of high-frequency episodic migraine. METHODS: In this multicentre, randomised, double-blind, placebo-controlled, phase 2b study, we enrolled men and women (aged 18-65 years) from 62 sites in the USA who had migraine headaches 8-14 days per month...
November 2015: Lancet Neurology
https://www.readbyqxmd.com/read/26432181/safety-tolerability-and-efficacy-of-tev-48125-for-preventive-treatment-of-chronic-migraine-a-multicentre-randomised-double-blind-placebo-controlled-phase-2b-study
#10
RANDOMIZED CONTROLLED TRIAL
Marcelo E Bigal, Lars Edvinsson, Alan M Rapoport, Richard B Lipton, Egilius L H Spierings, Hans-Christoph Diener, Rami Burstein, Pippa S Loupe, Yuju Ma, Ronghua Yang, Stephen D Silberstein
BACKGROUND: Benefits of calcitonin-gene related peptide (CGRP) inhibition have not been established in chronic migraine. Here we assess the safety, tolerability, and efficacy of two doses of TEV-48125, a monoclonal anti-CGRP antibody, in the preventive treatment of chronic migraine. METHODS: In this multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel-group phase 2b study, we enrolled men and women (aged 18-65 years) from 62 sites in the USA who had chronic migraine...
November 2015: Lancet Neurology
https://www.readbyqxmd.com/read/26017524/emerging-treatments-for-the-primary-headache-disorders
#11
REVIEW
Nathaniel M Schuster, Sarah Vollbracht, Alan M Rapoport
Migraine and cluster headache are common, episodic, often chronic and disabling disorders of the brain. Although there are many standard treatment techniques, none are ideal. This article reviews various novel pharmacologic and device-related treatments for migraine and cluster headache. Emphasis is given to recent advances in the development of monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) and its receptor, including promising results from phase 2 trials studying the safety and efficacy of LY2951742, ALD403 and TEV-48125, three anti-CGRP mAbs...
May 2015: Neurological Sciences
https://www.readbyqxmd.com/read/25754596/tev-48125-a-review-of-a-monoclonal-cgrp-antibody-in-development-for-the-preventive-treatment-of-migraine
#12
REVIEW
Sarah Walter, Marcelo E Bigal
Calcitonin gene-related peptide (CGRP) is a 37-amino-acid neuropeptide whose involvement in migraine pathophysiology is well established. Originally migraine was believed to be a disease of the vasculature, but research has highlighted this to be a disease of the brain with CGRP playing an important role. While targeting CGRP using small molecule antagonists against the receptor has been effective, long-term use of these agents has not been possible due to safety concerns and/or formulation challenges. Recent advances in therapeutic antibodies have opened up new possibilities for treatment of migraine...
March 2015: Current Pain and Headache Reports
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