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Farbod Khaleghi, Eric C Nemec
Brivaracetam (Briviact): a novel adjunctive therapy for partial-onset seizures.
February 2017: P & T: a Peer-reviewed Journal for Formulary Management
Meir Bialer, Svein I Johannessen, René H Levy, Emilio Perucca, Torbjörn Tomson, H Steve White
The Thirteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIII) took place in Madrid, Spain, on June 26-29, 2016, and was attended by >200 delegates from 31 countries. The present Progress Report provides an update on experimental and clinical results for drugs presented at the Conference. Compounds for which summary data are presented include an AED approved in 2016 (brivaracetam), 12 drugs in phase I-III clinical development (adenosine, allopregnanolone, bumetanide, cannabidiol, cannabidivarin, 2-deoxy-d-glucose, everolimus, fenfluramine, huperzine A, minocycline, SAGE-217, and valnoctamide) and 6 compounds or classes of compounds for which only preclinical data are available (bumetanide derivatives, sec-butylpropylacetamide, FV-082, 1OP-2198, NAX 810-2, and SAGE-689)...
January 23, 2017: Epilepsia
Martin J Brodie
This paper discusses the issues surrounding the tolerability and safety of the commonly used antiepileptic drugs (AEDs) in adolescents and adults. The content includes dose-related adverse effects, idiosyncratic reactions, behavioural and psychiatric comorbidities, chronic problems, enzyme induction and teratogenesis. Twenty-one AEDs are discussed in chronological order of their introduction into the UK, starting with phenobarbital and ending with brivaracetam. Wherever possible, advice is given on anticipating, recognising and managing these issues and thereby improving the lives of people with epilepsy, most of whom will need to take one or more of these agents for life...
January 18, 2017: CNS Drugs
Martyn D Wood, Michel Gillard
OBJECTIVE: Brivaracetam (BRV) and levetiracetam (LEV) are effective antiepileptic drugs that bind selectively to the synaptic vesicle 2A (SV2A) protein. However, BRV differs from LEV in that it exhibits more potent and complete seizure suppression in animal models including in amygdala-kindled mice, where BRV afforded nearly complete seizure suppression. This raises the possibility that aside from potency differences, BRV and LEV may interact differently with the SV2A protein, which is not apparent in radioligand-binding competition studies...
December 24, 2016: Epilepsia
Clara Mukuria, Tracey Young, Anju Keetharuth, Simon Borghs, John Brazier
PURPOSE: Preference-based measures are required to measure the impact of interventions for cost-effectiveness analysis. This study assessed the psychometric performance of the EQ-5D-3L in adults with uncontrolled focal (partial-onset) seizures. METHODS: Data from three Phase III studies of an antiepileptic drug (adjunctive brivaracetam; n = 1095) were used. Analysis included correlations between EQ-5D-3L and Quality of Life in Epilepsy Inventory (QOLIE-31P) and seizure frequency...
December 21, 2016: Quality of Life Research
Pavel Klein, Martin E Johnson, Jimmy Schiemann, John Whitesides
Time to onset of sustained ≥50% responder status (SRS) was assessed for the pooled patient population receiving brivaracetam (BRV) 50, 100, or 200 mg/day or placebo in three randomized phase III studies (NCT00464269, NCT00490035, and NCT01261325). Patients were aged ≥16 years with well-characterized focal (partial-onset) seizures (FS) uncontrolled by 1-2 concomitant antiepileptic drugs. After an 8-week baseline period, patients received study drug without up-titration for a 12-week (84-day) treatment period...
December 18, 2016: Epilepsia
M Charokopou, J Sander, R Saha, S Beard, R Kidd, E Coward, J Plumb
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
M Charokopou, R Harvey, K Sristava, R Townsend, S Borghs
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Li-Na Zhu, Deng Chen, Tao Chen, Da Xu, Si-Han Chen, Ling Liu
PURPOSE: To comprehensively evaluate the adverse events (AEs) significantly associated with brivaracetam (BRV) treatment in a large selection of randomized control trials. METHODS: We conducted an online database search using Pubmed, Embase, Cochrane Online Library, and for all available randomized control trials (RCTs) that investigated the therapeutic effects of brivaracetam. Serious AEs (SAEs), withdrawal, and treatment-emergent adverse effects were then assessed for their association with brivaracetam...
November 14, 2016: Seizure: the Journal of the British Epilepsy Association
Nicolas Couvrat, Julien Mahieux, Baptiste Fours, Yohann Cartigny, Eric Schenkel, Luc Aerts, Luc Quéré, Gérard Coquerel
Brivaracetam, or (2S)-2-[(4R)-2-oxo-4-propyl-pyrrolidin-1-yl] butanamide, is an active pharmaceutical ingredient designed for the treatment of epilepsy. During the development of the IV administration mode, a liquid-liquid miscibility gap has been observed with pure water, isotonic and hypertonic solutions (vehicle at 0.9% w/w and 5%w/w NaCl respectively). The study reveals that the NaCl concentration has a direct impact on the extent of the demixing domain; from a sub-micronic demixing in pure water towards a macroscopic miscibility gap in hypertonic aqueous solutions...
December 30, 2016: International Journal of Pharmaceutics
Christian Brandt, Theodor W May, Christian G Bien
Brivaracetam (BRV) is a novel antiepileptic drug recently licensed for the treatment of partial epilepsy in adults and adolescents over 16 years old. Like levetiracetam (LEV), it is a ligand of the synaptic vesicle protein SV2A. BRV has been shown in animal models and in studies using human brain slices to have a higher SV2A affinity and faster penetration into the brain. Its efficacy and safety have been shown in several randomized, controlled studies. The recommended initial dose is 50-100 mg, divided into two daily doses...
November 2016: Therapeutic Advances in Neurological Disorders
Michael A Rogawski
Since the 1970s, racetams have been in use as cognitive enhancers. Levetiracetam was discovered to have antiseizure activity in animal models and was then found to bind to SV2A in synaptic and endocrine vesicles. Brivaracetam, an analog of levetiracetam, was identified in a medicinal chemistry campaign with the objective of discovering analogs with higher affinity at racetam-binding sites and greater antiseizure potency.
October 20, 2016: Cell
Francesco Brigo, Nicola Luigi Bragazzi, Raffaele Nardone, Eugen Trinka
BACKGROUND: Brivaracetam (BRV), eslicarbazepine acetate (ESL), lacosamide (LCM), and perampanel (PER) have been recently marketed as adjunctive treatments for focal onset seizures. To date, no randomized controlled trial (RCT) has directly compared BRV with ESL, LCM, or PER. PURPOSE: To compare BRV with the other add-on AEDs in patients with uncontrolled focal epilepsy, estimating their efficacy and tolerability through an adjusted, common-reference based indirect comparison meta-analysis...
November 2016: Seizure: the Journal of the British Epilepsy Association
Annelieke C Kruithof, Shikiko Watanabe, Pierre Am Peeters, Marieke L de Kam, Rob Gja Zuiker, Jasper Stevens, Joop Ma van Gerven, Armel Stockis
This double-blind, randomized, three-way crossover study explored the potential pharmacokinetic and pharmacodynamic interactions between ethanol and brivaracetam in 18 healthy males, as required for the development of CNS-active drugs. Subjects received (A) ethanol+brivaracetam, (B) ethanol placebo+brivaracetam and (C) ethanol+brivaracetam placebo. Ethanol was infused as a 5.5-hour intravenous clamp with the first 0.5-hour as loading phase to a target level of 0.6 g/L, and brivaracetam was orally administered as a single 200 mg dose...
September 20, 2016: Journal of Psychopharmacology
Roberto Michelucci, Elena Pasini, Patrizia Riguzzi, Eva Andermann, Reetta Kälviäinen, Pierre Genton
Generalized motor seizures, usually tonic-clonic, tonic-vibratory, myoclonic or clonic, and stimulus-sensitive/action myoclonus are typical features of progressive myoclonus epilepsies (PMEs). Despite the introduction of many anticonvulsants, the treatment of these symptoms, particularly myoclonus, remains challenging, due to the incomplete and often transitory effects of most drugs. Moreover, treatment is only symptomatic, since therapy targeting the underlying aetiology for these genetic conditions is in its infancy...
September 1, 2016: Epileptic Disorders: International Epilepsy Journal with Videotape
Brian D Moseley, Michael R Sperling, Ali A Asadi-Pooya, Anyzeila Diaz, Sami Elmouft, Jimmy Schiemann, John Whitesides
PURPOSE: Secondarily generalized tonic-clonic seizures (SGTCS) are among the most devastating types of seizures, contributing to increased morbidity and mortality. Brivaracetam (BRV), a selective, high-affinity ligand for synaptic vesicle 2A (SV2A), has been shown to be useful for the adjunctive treatment of focal seizures. We sought to determine its specific efficacy in treating SGTCS. METHODS: Data were pooled from three Phase III studies (NCT00490035; NCT00464269; NCT01261325) of adults with focal seizures taking 1-2 antiepileptic drugs (AEDs) who received placebo or BRV 50-200mg/day without titration over a 12-week treatment period...
September 3, 2016: Epilepsy Research
Martin J Brodie, John Whitesides, Jimmy Schiemann, Joseph D'Souza, Martin E Johnson
INTRODUCTION: This analysis was conducted to assess the tolerability, safety, and efficacy of brivaracetam (BRV) for adjunctive treatment of focal (partial-onset) seizures in patients aged ≥65 years. METHODS: Safety/tolerability and efficacy data for patients aged ≥65 years were pooled from three randomized, double-blind, placebo-controlled, fixed-dose Phase III studies (NCT00490035, NCT00464269, and NCT01261325). Data were pooled by treatment group: placebo or the proposed therapeutic dose range of 50-200 mg/day: BRV 50, 100, 200mg/day...
August 18, 2016: Epilepsy Research
Sheridan M Hoy
Brivaracetam (Briviact(®); BRIVLERA™) is a high affinity synaptic vesicle protein 2A (SV2A) ligand available orally (as a tablet or solution) or intravenously (as a bolus or infusion) in various countries worldwide, including the USA, Canada and those of the EU. It is approved as adjunctive therapy for the treatment of partial-onset seizures (POS) in adults (aged ≥18 years) [USA, EU and Canada] and adolescents (aged 16 to <18 years) [USA and EU] with epilepsy. In multinational, phase III studies in adults and adolescents (aged ≥16 years), oral brivaracetam as adjunctive therapy to other antiepileptic drugs (AEDs) was generally associated with significant median percent reductions over placebo in seizure frequency and significant improvements in the proportion of patients achieving a ≥50 % reduction in seizure frequency compared with placebo...
August 2016: CNS Drugs
Daniel A Hussar, Jerry Rachel George
No abstract text is available yet for this article.
July 2016: Journal of the American Pharmacists Association: JAPhA
(no author information available yet)
No abstract text is available yet for this article.
July 18, 2016: Medical Letter on Drugs and Therapeutics
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