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
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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
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| 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 | |
| NorthStar RxLLC | 16714-550 | ORAL | 150 mg in 1 1 | 2/14/2024 | |
| Tris Pharma Inc | 27808-246 | ORAL | 200 mg in 1 1 | 6/26/2023 | |
| Amneal Pharmaceuticals LLC | 65162-926 | ORAL | 200 mg in 1 1 | 2/13/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Lacosamide Injection | 国药准字H20243768 | 化学药品 | 注射剂 | 5/21/2024 | |
| Lacosamide Injection | 国药准字H20223813 | 化学药品 | 注射剂 | 11/8/2022 | |
| Lacosamide Injection | 国药准字H20223941 | 化学药品 | 注射剂 | 12/30/2022 | |
| Lacosamide Injection | 国药准字H20243016 | 化学药品 | 注射剂 | 1/9/2024 | |
| Lacosamide Injection | 国药准字H20223493 | 化学药品 | 注射剂 | 7/7/2022 | |
| Lacosamide Injection | 国药准字H20233243 | 化学药品 | 注射剂 | 3/7/2023 | |
| Lacosamide Injection | H20190060 | 化学药品 | 注射剂 | 12/18/2019 | |
| Lacosamide Injection | 国药准字H20243114 | 化学药品 | 注射剂 | 1/30/2024 | |
| Lacosamide Injection | 国药准字H20249270 | 化学药品 | 注射剂 | 11/5/2024 | |
| Lacosamide Injection | 国药准字H20244927 | 化学药品 | 注射剂 | 9/19/2024 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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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 |
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