Brivaracetam

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Structural formula
Structural formula brivaracetam
General
Non-proprietary name Brivaracetam
other names
  • (2 S ) -2 - [(4 R ) -2-oxo-4-propylpyrrolidin-1-yl] butanamide
  • UCB 34714
Molecular formula C 11 H 20 N 2 O 2
External identifiers / databases
CAS number 357336-20-0
EC number 801-184-2
ECHA InfoCard 100.118.642
PubChem 9837243
ChemSpider 8012964
DrugBank DB05541
Wikidata Q408099
Drug information
ATC code

N03 AX23

Drug class

Anticonvulsant

Mechanism of action

Ligand on synaptic vesicle protein 2A

properties
Molar mass 212.29 g · mol -1
safety instructions
Please note the exemption from the labeling requirement for drugs, medical devices, cosmetics, food and animal feed
GHS labeling of hazardous substances
07 - Warning

Caution

H and P phrases H: 302
P: ?
As far as possible and customary, SI units are used. Unless otherwise noted, the data given apply to standard conditions .

Brivaracetam is an antiepileptic effective drug . It was developed by the Belgian company UCB and approved in January 2016 in the EU and in February 2016 in the USA under the name Briviact for the additional treatment of focal epilepsy attacks in adults and adolescents aged 16 and over. Focal seizures are seizures that start on one side of the brain. If spread, they can affect larger areas on either side of the brain ("secondary generalization").

pharmacology

Mechanism of action

Brivaracetam is a ligand on synaptic vesicle protein 2A ( SV2A ). In addition inhibits it voltage-dependent sodium channels in the nervous system . The exact role of SV2A is not yet fully understood. Chemically, brivaracetam is derived from levetiracetam , with its higher affinity for the SV2A receptor having a stronger anticonvulsant activity in animal models.

Pharmacokinetics

Brivaracetam is almost completely absorbed in the gastrointestinal tract and excreted via the kidneys . The plasma half-life is 9 hours. Brivacetam has a low potential for drug interaction.

Early benefit assessment

In Germany, since 2011, newly approved drugs with new active ingredients must be subjected to an " early benefit assessment " by the Federal Joint Committee (G-BA) in accordance with Section 35a SGB ​​V if the pharmaceutical manufacturer wants to achieve a higher sales price than just the fixed amount . Only if there is an additional benefit can the pharmaceutical manufacturer negotiate a price with the umbrella association of statutory health insurance companies. The dossier evaluations, on the basis of which the G-BA makes its decisions, are created by the Institute for Quality and Efficiency in Health Care (IQWiG) .

Brivaracetam underwent two early benefit assessments due to an extension of approval. In 2016, the focus was on the additional treatment of partial seizures with or without secondary generalization in adults and adolescents aged 16 and over. In 2018 there was an assessment for children and young people from 4 to under 16 years of age. In both cases, the G-BA came to the conclusion that an additional benefit compared to the respective ACT is not proven.

literature

Web links

Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for: Brivaracetam

Individual evidence

  1. Template: CL Inventory / not harmonized There is not yet a harmonized classification for this substance . A labeling of (S) -2 - ((R) -2-oxo-4-propylpyrrolidin-1-yl) butanamide in the Classification and Labeling Inventory of the European Chemicals Agency (ECHA), accessed on 28 December 2019.
  2. Michael Freissmuth, Stefan Böhm, Stefan Offermanns: Pharmakologie und Toxikologie: From the molecular bases for pharmacotherapy 2012, p. 308.
  3. A16-08 Brivaracetam - Benefit assessment according to Section 35a SGB V; Accessed March 26, 2020.
  4. A16-38 Brivaracetam - Addendum to Commission A16-08; Accessed March 26, 2020.
  5. A18-48 Brivaracetam (epilepsy) - Benefit assessment according to Section 35a SGB V; Accessed March 26, 2020.
  6. ↑ Benefit assessment procedure for the active ingredient brivaracetam (focal seizures in epilepsy, ≥ 16 years); Accessed March 26, 2020.
  7. ↑ Benefit assessment procedure for the active ingredient brivaracetam (new area of ​​application: focal seizures in epilepsy, additional therapy, 4 to <16 years); Accessed March 26, 2020.