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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...
November 3, 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...
September 24, 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
A Strzelczyk, I Steinig, K M Klein, L M Willems, S Knake, F Rosenow, S Bauer
Brivaracetam is the latest antiepileptic drug to be approved for adjunctive therapy in focal epilepsy and has a high affinity as a SV2A ligand. The aim of this review article is to summarize the data from the pivotal studies in which more than 2000 patients received brivaracetam. A significant median reduction in seizures from 30.5 % to 53.1 % for 50 mg/day, from 32.5 % to 37.2 % for 100 mg/day and 35.6 % for 200 mg/day could be demonstrated. Overall brivaracetam appears to be well-tolerated, with fatigue, dizziness and somnolence being the main adverse side effects...
July 7, 2016: Der Nervenarzt
Dennis J Cada, Uzoma Mbogu, Ross J Bindler, Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
June 2016: Hospital Pharmacy
Armel Stockis, Jan Hartstra, Muriel Mollet, Salah Hadi
OBJECTIVE: To determine the bioequivalence of brivaracetam oral tablet formulations (10, 75, and 100 mg) versus 50 mg oral tablet and to compare the bioavailability of brivaracetam 100 mg intravenous (i.v.) bolus versus 50 and 100 mg tablets, in healthy participants. METHODS: Phase 1, randomized, open-label, five-period crossover study. Participants received five single doses of brivaracetam: 10, 50 (reference), 75, and 100 mg oral tablets; 100 mg, i.v., bolus injection...
August 2016: Epilepsia
Elinor Ben-Menachem, Rūta Mameniškienė, Pier Paolo Quarato, Pavel Klein, Jessica Gamage, Jimmy Schiemann, Martin E Johnson, John Whitesides, Belinda McDonough, Klaus Eckhardt
OBJECTIVE: To assess the efficacy, safety, and tolerability of adjunctive brivaracetam (BRV), a selective, high-affinity ligand for SV2A, for treatment of partial-onset (focal) seizures (POS) in adults. METHODS: Data were pooled from patients (aged 16-80 years) with POS uncontrolled by 1 to 2 antiepileptic drugs receiving BRV 50, 100, or 200 mg/d or placebo, without titration, in 3 phase III studies of BRV (NCT00490035, NCT00464269, and NCT01261325, ClinicalTrials...
July 19, 2016: Neurology
Christian Otoul, Shikiko Watanabe, Suzanne McCabe, Armel Stockis
Brivaracetam, a selective high-affinity ligand for synaptic vesicle protein 2A, was recently approved as adjunctive treatment for patients with focal (partial-onset) seizures. In a randomized, open-label, 2-way crossover study, 24 healthy participants received brivaracetam (5 mL of 10 mg/mL oral solution or 50-mg oral film-coated tablet) (day 1) and a single dose of the alternative formulation (day 8) under fasting conditions to assess relative bioavailability and bioequivalence between the 2 formulations. Plasma samples were collected sequentially until 36 hours postdose to determine brivaracetam plasma concentrations...
June 8, 2016: Clinical Pharmacology in Drug Development
Manuel Toledo, John Whitesides, Jimmy Schiemann, Martin E Johnson, Klaus Eckhardt, Belinda McDonough, Simon Borghs, Patrick Kwan
OBJECTIVES: To report pooled safety/tolerability and seizure outcome data from adults with uncontrolled partial-onset (focal) seizures (POS) receiving adjunctive brivaracetam (BRV) during phase IIb/III and long-term follow-up (LTFU) studies. METHODS: Seizure outcome data were pooled from phase IIb (NCT00175929 and NCT00175825), III/IIIb (NCT00490035, NCT00464269, NCT00504881, and NCT01261325) and associated LTFU studies (NCT00175916, NCT00150800, and NCT01339559)...
July 2016: Epilepsia
G Zaccara
Brivaracetam was approved in the E.U. and U.S. at the beginning of 2016 for the adjunctive treatment of focal epilepsies in patients over 16 years of age. This compound is a novel high-affinity synaptic vesicle glycoprotein 2A (SV2A) ligand, with a selectivity for this protein that is 10- to 30-fold higher than that shown by levetiracetam. Preclinical studies show that brivaracetam might have a stronger anticonvulsant effect and distributes in the brain more quickly, when compared to levetiracetam. The agent has linear and simple pharmacokinetics and a low interaction potential...
April 2016: Drugs of Today
Marco Mula
INTRODUCTION: Drugs marketed during the last few years (i.e. Lacosamide, Ruifinamide, Eslicarbazepine acetate, Brivaracetam and Perampanel) are increasingly regarded as third generation AEDs. This paper presents available data about monotherapy with third generation drugs and on-going clinical trials with special attention to the existing debate about monotherapy license in epilepsy. AREAS COVERED: References were identified by searches of Medline/PubMed. In addition, currently active studies for these AEDs were identified in the ClinicalTrials...
September 2016: Expert Review of Neurotherapeutics
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