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TEV-48125 ( anti- CGRP)

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https://www.readbyqxmd.com/read/28644160/calcitonin-gene-related-peptide-targeted-therapies-for-migraine-and-cluster-headache-a-review
#1
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
#2
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/27339365/anti-cgrp-monoclonal-antibodies-in-migraine-current-perspectives
#3
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/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
#4
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
#5
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
#6
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
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