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Stephan Arnold, Vincent Badalamenti, Anyzeila Diaz, Teresa Gasalla, Cindy McShea, John Whitesides, Toufic Fakhoury
Brivaracetam (BRV), a selective, high-affinity ligand for synaptic vesicle protein 2A, is a new antiepileptic drug (AED) approved for monotherapy (in the USA) and adjunctive treatment of focal (partial-onset) seizures in adults, at a dose range of 50-200 mg/day taken in two equal doses, with a recommended starting dose of 100 mg/day. Two Phase III, randomized, double-blind, multicenter, historical-controlled, conversion-to-monotherapy studies (N01276, NCT00698581; N01306, NCT00699283) were conducted to evaluate the efficacy, safety, and tolerability of conversion to BRV 50 mg/day monotherapy in adults with uncontrolled focal seizures...
February 12, 2018: Epilepsy Research
Felix Zahnert, Kristina Krause, Ilka Immisch, Lena Habermehl, Iris Gorny, Izabella Chmielewska, Leona Möller, Anna M Weyand, Peter M Mross, Jan Wagner, Katja Menzler, Susanne Knake
Objectives: To assess first clinical experiences with brivaracetam (BRV) in the treatment of epilepsies. Methods: Data on patients treated with BRV from February to December 2016 and with at least one clinical follow-up were collected from electronic patient records. Data on safety and efficacy were evaluated retrospectively. Results: In total, 93 patients were analyzed; 12 (12.9%) received BRV in monotherapy. The mean duration to follow-up was 4...
2018: Frontiers in Neurology
Arne Reimers, Jon Andsnes Berg, Margrete Larsen Burns, Eylert Brodtkorb, Svein I Johannessen, Cecilie Johannessen Landmark
Background and objective: Laboratories sometimes use different reference ranges for the same antiepileptic drug (AED), particularly for new and poorly investigated drugs. This may contribute to misunderstandings, concerns or inappropriate dose changes, which in turn may affect therapeutic effect, drug safety or treatment adherence. Therefore, the Norwegian Association of Clinical Pharmacology wished to update and harmonize the reference ranges for AEDs and establish national guidelines for Norway...
2018: Drug Design, Development and Therapy
Isabel Barrachina-Martínez, David Vivas-Consuelo, Anna Piera-Balbastre
In the original publication, the abstract, conclusion was incorrectly published.
February 20, 2018: Clinical Drug Investigation
Selim Benbadis, Pavel Klein, Jimmy Schiemann, Anyzeila Diaz, Sami Elmoufti, John Whitesides
OBJECTIVE: The objective was to assess the efficacy and safety of adjunctive brivaracetam (BRV) with concomitant use of lamotrigine (LTG) or topiramate (TPM) in patients with uncontrolled focal seizures. METHODS: Data were pooled from three randomized, placebo-controlled Phase III studies (NCT00490035/N01252, NCT00464269/N01253, NCT01261325/N01358) of adults with focal (partial-onset) seizures. Patients taking concomitant levetiracetam were excluded from the efficacy populations, but included in the safety populations...
January 23, 2018: Epilepsy & Behavior: E&B
Pavel Klein, Anyzeila Diaz, Teresa Gasalla, John Whitesides
Brivaracetam (BRV; Briviact) is a new antiepileptic drug (AED) approved for adjunctive treatment of focal (partial-onset) seizures in adults. BRV is a selective, high-affinity ligand for synaptic vesicle 2A (SV2A) with 15- to 30-fold higher affinity than levetiracetam, the first AED acting on SV2A. It has high lipid solubility and rapid brain penetration, with engagement of the target molecule, SV2A, within minutes of administration. BRV has potent broad-spectrum antiepileptic activity in animal models. Phase I studies indicated BRV was well tolerated and showed a favorable pharmacokinetic profile over a wide dose range following single (10-1,000 mg) and multiple (200-800 mg/day) oral dosing...
2018: Clinical Pharmacology: Advances and Applications
Linda J Stephen, Martin J Brodie
Brivaracetam (BRV), the n -propyl analogue of levetiracetam (LEV), is the latest antiepileptic drug (AED) to be licensed in Europe and the USA for the adjunctive treatment of focal-onset seizures with or without secondary generalization in patients aged 16 years or older. Like LEV, BRV binds to synaptic vesicle protein 2A (SV2A), but BRV has more selective binding and a 15- to 30-fold higher binding affinity than LEV. BRV is more effective than LEV in slowing synaptic vesicle mobilization and the two AEDs may act at different binding sites or interact with different conformational states of the SV2A protein...
2018: Therapeutic Advances in Neurological Disorders
Nathalie T Sanon, Jonathan Gagné, Daniele C Wolf, Soumia Aboulamer, Ciprian M Bosoi, Alexe Simard, Estelle Messiet, Sébastien Desgent, Lionel Carmant
Levetiracetam (LEV), and its newer selective analog brivaracetam (BRV), are two seizure medications that share an innovative mechanism of action targeting the Synaptic Vesicle Protein 2A (SV2A), altering neurotransmitter release and decreasing seizure frequency. Behavioral changes are the most significant adverse effects reported by patients taking LEV. We hypothesize that BRV, the more potent SV2A analog, could exert less behavioral side effects, as it requires lower doses than LEV. Using Kainic Acid (KA)-treated and control rats, we measured adverse behavioral effect profiles of LEV, BRV, or Saline, on social and nonsocial behaviors...
December 26, 2017: Epilepsy & Behavior: E&B
V A Karlov, P N Vlasov, I A Zhidkova, M Ya Kissin, A V Lebedeva, L V Lipatova, V R Mkrtchyan, K Yu Mukhin, I G Rudakova
The newest antiepileptic drug (AED) brivaracetam (Briviac, UCB Pharma) (BRV) was approved in the Russian Federation in 2017 as an adjuvant therapy for the treatment of partial seizures with/without secondary generalization in adults and adolescents over 16 years old with epilepsy. This review contains the data of BRV preclinical studies, pharmacokinetic profile and the results of comparative study of BRV and LEV. The results of main studies of efficacy and tolerability with pooled analysis as well as data from meta-analysis are presented...
2017: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
Charlotte S Kwok, Emily L Johnson, Gregory L Krauss
Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients...
November 2017: CNS Drugs
Zhu Li-Na, Chen Deng, Wang Hai-Jiao, Xu Da, Tan Ge, Liu Ling
PURPOSE: Eslicarbazepine (ESL), Lacosamide (LAC), Perampanel (PER) and Brivaracetam (BRV), have recently been marketed as third-generation antiepileptic drugs (AEDs). We conducted a meta-analysis to indirectly compare overall efficacy and tolerability between third-generation AEDs in uncontrolled focal epilepsy. METHODS: We performed an online database search using Pubmed, Embase, Cochrane Online Library, and for all available randomized controlled trials (RCTs) that investigated the therapeutic effects over a range of AED doses versus placebo...
January 2018: Epilepsy Research
Gemma Ortega, Laura Abraira, Glòria Martí, Manuel Quintana, Gonzalo Mazuela, Estevo Santamarina, Xavier Salas-Puig, Manuel Toledo
OBJECTIVES: To assess state and trait anger, adjusted by epilepsy type, seizure control, anxiety-depression status and quality of life, in patients treated with brivaracetam (BRV) from an open study. METHODS: We evaluated prospectively consecutive patients with partial onset seizures in an open-label study. Patients had 5 years or longer of epilepsy and were taking between 1 and 3 antiepileptic drugs. They were treated with BRV and compared with a control group selected from outpatients attending our epilepsy unit who met the following criteria: age ≥16 years and diagnosis of epilepsy with focal-onset seizures at least 1 year before inclusion in the study...
January 2018: Clinical Neuropharmacology
Alberto Grande-Martín, David Sopelana-Garay, José Manuel Pardal-Fernández, Rosa María Sánchez-Honrubia, Álvaro Abelardo Sánchez-Larsen
Brivaracetam is currently indicated as adjunctive therapy for patients with focal-onset seizures with or without secondary generalization. However, it has been suggested that it could provide broad-spectrum efficacy given its similarity to levetiracetam and based on the results from preclinical studies and others of patients with generalized epilepsy. We present the case of a woman with refractory idiopathic generalized epilepsy and absence seizures with dramatic response to brivaracetam. Our report supports a consideration of treatment with this new antiepileptic drug on a case-by-case basis in patients with refractory generalized epilepsy, while we await further studies on this topic...
November 21, 2017: Epileptic Disorders: International Epilepsy Journal with Videotape
Kerri A Schoedel, Armel Stockis, Edward M Sellers
BACKGROUND: Brivaracetam is a new antiepileptic drug indicated for adjunctive treatment of focal seizures in adults at a dose of 50-200mg/day taken in two equal doses. The objective of this study was to evaluate the abuse potential of brivaracetam compared with alprazolam (positive control), placebo, and levetiracetam. METHODS: This was a randomized, double-blind, triple-dummy, crossover study in healthy male and female recreational central nervous system (CNS) depressant users aged 18-55years, who could distinguish between the subjective effects of alprazolam 2mg and placebo...
November 15, 2017: Epilepsy & Behavior: E&B
Kelsey L Hawkins, Barry E Gidal
There has been growing recognition of the possible abuse potential of newer generation antiepileptic drugs, and several of these agents have been categorized as controlled substances in the United States. To properly schedule a new medication, the abuse potential, or the potential for a drug to be used for its nonmedical positive subjective effects, must be determined. Performing a human abuse potential study is one step in the overall abuse potential assessment. These studies analyze the abuse potential of a new drug in a very specific population of known recreational drug users...
December 2017: Epilepsy & Behavior: E&B
Manuel Toledo, Rebecca Beale, Jennifer S Evans, Sara Steeves, Sami Elmoufti, Rebecca Townsend, John Whitesides, Simon Borghs
Antiepileptic drug (AED) retention rates are frequently reported in the literature and used to inform clinical decision-making, but methodological differences in the determination of retention rates make comparisons between trials difficult. Open-label extension (OLE) studies of AEDs in patients with focal epilepsy were identified from the literature. Retention calculation methods were reviewed, and published AED retention rates qualitatively compared with corresponding data for brivaracetam (BRV), a synaptic vesicle protein 2A ligand...
October 10, 2017: Epilepsy Research
Pavel Klein, Selim R Benbadis, Anyzeila Diaz, Brian D Moseley, Elinor Ben-Menachem
No abstract text is available yet for this article.
October 17, 2017: Neurology
Rik Schoemaker, Janet R Wade, Joseph D'Souza, Armel Stockis
Brivaracetam is a selective, high-affinity ligand for synaptic vesicle protein 2A, recently approved as adjunctive therapy in the treatment of focal (partial-onset) seizures in patients 16 years of age and older with epilepsy. The goal of the present analysis was to determine if the dose-response of brivaracetam as monotherapy would fall within the range associated with brivaracetam efficacy as adjunctive therapy. An existing brivaracetam population pharmacokinetic model consisting of first-order absorption, single compartment distribution, and first-order elimination components was extended by estimating the clearance changes due to co-administration of 12 widely prescribed AEDs...
November 2017: Epilepsy Research
Qingting Hu, Fang Zhang, Wenhui Teng, Fangfang Hao, Jing Zhang, Mingxiao Yin, Naidong Wang
The optimal combination of antiepileptic drugs (AEDs) for the treatment of refractory partial-onset epilepsy is a perpetual point of debate. While several network meta-analyses (NMAs) have been published, conclusions remain controversial, especially since newer AEDs have been introduced. In our review, we included the newer AEDs to evaluate the comparative efficacy and safety of AEDs for the treatment of refractory partial-onset epilepsy. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials (Cochrane Library 2017, Issue 1) from their inception to February 18, 2017...
January 2018: Journal of Neurology
Rik Schoemaker, Janet R Wade, Armel Stockis
INTRODUCTION: Prediction of brivaracetam effects in children was obtained by scaling an existing adult pharmacokinetic/pharmacodynamic (PK/PD) model for brivaracetam to children, using an existing population PK model for brivaracetam in children. The scaling was supported by estimating the change from adults to children in the concentration-effect relationship parameters for levetiracetam, a compound interacting with the same target protein (synaptic vesicle protein SV2A). METHODS: The existing adult PK/PD model for brivaracetam was applied to a combined adult-pediatric dataset of levetiracetam...
September 7, 2017: Clinical Pharmacokinetics
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