Overview
Lacosamide is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain. Recent studies indicate that Lacosamide only affects those neurons which are depolarized or active for long periods of time, typical of neurons at the focus of an epileptic seizure, as opposed to other antiepileptic drugs such as carbamazepine or lamotrigine which slow the recovery from inactivation and reduce the ability of neurons to fire action potentials.
Indication
Lacosamide is indicated for the treatment of partial-onset seizures in patients aged one month and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients aged four years and older.
Associated Conditions
- Epilepsy, Primary Generalized Tonic-Clonic Seizures
- Partial-Onset Seizures
- Status Epilepticus
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2011/10/12 | Phase 1 | Completed | |||
2011/09/12 | Not Applicable | Terminated | |||
2011/06/27 | Not Applicable | Completed | |||
2011/06/17 | Phase 3 | Terminated | |||
2011/06/17 | Phase 1 | Completed | |||
2011/04/29 | Phase 3 | Completed | |||
2010/11/18 | Phase 3 | Completed | |||
2010/11/07 | N/A | Completed | |||
2010/11/05 | Phase 4 | Completed | |||
2010/08/27 | Phase 4 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Health Packaging | 60687-687 | ORAL | 100 mg in 1 1 | 9/27/2023 | |
| NorthStar RxLLC | 16714-552 | ORAL | 200 mg in 1 1 | 2/14/2024 | |
| Westminster Pharmaceuticals, LLC | 69367-352 | INTRAVENOUS | 10 mg in 1 mL | 7/29/2025 | |
| Alembic Pharmaceuticals Inc. | 62332-174 | ORAL | 200 mg in 1 1 | 11/9/2023 | |
| Aurobindo Pharma Limited | 65862-750 | ORAL | 200 mg in 1 1 | 3/13/2024 | |
| Glenmark Pharmaceuticals Inc. USA | 68462-681 | ORAL | 200 mg in 1 1 | 11/14/2023 | |
| PAI Holdings, LLC | 0121-4048 | ORAL | 200 mg in 20 mL | 8/30/2023 | |
| Aurobindo Pharma Limited | 65862-748 | ORAL | 100 mg in 1 1 | 3/13/2024 | |
| Hainan Poly Pharm. Co., Ltd. | 14335-330 | INTRAVENOUS | 10 mg in 1 mL | 3/25/2024 | |
| Golden State Medical Supply, Inc. | 51407-723 | ORAL | 150 mg in 1 1 | 2/8/2024 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VIMCOSA lacosamide 150 mg tablet blister pack | 353572 | Medicine | A | 2/8/2022 | |
| LACORESS lacosamide 100 mg film-coated tablet blister pack | 337933 | Medicine | A | 5/11/2021 | |
| LACOSIMPAT lacosamide 150 mg film-coated tablets blister pack | 296751 | Medicine | A | 5/29/2019 | |
| GenRx LACOSAMIDE lacosamide 100 mg film-coated tablet blister pack | 230188 | Medicine | A | 9/30/2015 | |
| LACOSAMIDE Lupin lacosamide 150 mg film-coated tablets blister pack | 296768 | Medicine | A | 5/29/2019 | |
| LACOSIMPAT lacosamide 50 mg film-coated tablets blister pack | 296767 | Medicine | A | 5/29/2019 | |
| ALEMBIC LACOSAMIDE lacosamide 200 mg film-coated tablet blister pack | 337930 | Medicine | A | 5/11/2021 | |
| LACOSAMIDE APOTEX lacosamide 150 mg film-coated tablet blister pack | 230194 | Medicine | A | 9/30/2015 | |
| LACOSAMIDE SANDOZ lacosamide 150 mg film-coated tablet blister pack | 309011 | Medicine | A | 7/6/2021 | |
| LACOVIM lacosamide 200 mg tablet bottle | 353575 | Medicine | A | 2/8/2022 |
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AURO-LACOSAMIDE | auro pharma inc | 02475359 | Tablet - Oral | 150 MG | 10/1/2018 |
| ALEMBIC-LACOSAMIDE | 02472732 | Tablet - Oral | 50 MG | N/A | |
| PMS-LACOSAMIDE | 02474123 | Tablet - Oral | 150 MG | N/A | |
| MAR-LACOSAMIDE | marcan pharmaceuticals inc | 02487802 | Tablet - Oral | 50 MG | 10/4/2019 |
| LACOSAMIDE | sanis health inc | 02512882 | Tablet - Oral | 100 MG | 9/27/2021 |
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CESIVA 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Exeltis Healthcare S.L. | 83094 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| VIMPAT 10 MG/ML JARABE | 108470018 | JARABE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LACOSAMIDA CINFAMED 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 82995 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LACOSAMIDA INTAS 150 MG COMPRIMIDOS EFERVESCENTES EFG | Intas Third Party Sales 2005 S.L. | 89338 | COMPRIMIDO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LACOSAMIDA VIR 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Industria Quimica Y Farmaceutica Vir S.A. | 83341 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LACOSAMIDA STADA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 82973 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LACOSAMIDA ALEMBIC 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Alembic Pharmaceuticals Europe Limited | 85799 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| VIMPAT 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 08470011IP1 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| BALMID 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Intas Third Party Sales 2005 S.L. | 87319 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LACOSAMIDA ACCORD 10 MG/ML SOLUCION PARA PERFUSION EFG | 1171230026 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.