Overview
Carbidopa presents a chemical denomination of N-amino-alpha-methyl-3-hydroxy-L-tyrosine monohydrate. It potently inhibits aromatic amino acid decarboxylase (DDC) and due to its chemical properties, it does not cross the blood-brain barrier. Due to its activity, carbidopa is always administered concomitantly with levodopa. An individual formulation containing solely carbidopa was generated to treat nausea in patients where the combination therapy levodopa/carbidopa is not efficient reducing nausea. The first approved product by the FDA containing only carbidopa was developed by Amerigens Pharmaceuticals Ltd and approved on 2014. On the other hand, the combination treatment of carbidopa/levodopa was originally developed by Watson Labs but the historical information by the FDA brings back to the approval of this combination therapy developed by Mayne Pharma in 1992.
Background
Carbidopa presents a chemical denomination of N-amino-alpha-methyl-3-hydroxy-L-tyrosine monohydrate. It potently inhibits aromatic amino acid decarboxylase (DDC) and due to its chemical properties, it does not cross the blood-brain barrier. Due to its activity, carbidopa is always administered concomitantly with levodopa. An individual formulation containing solely carbidopa was generated to treat nausea in patients where the combination therapy levodopa/carbidopa is not efficient reducing nausea. The first approved product by the FDA containing only carbidopa was developed by Amerigens Pharmaceuticals Ltd and approved on 2014. On the other hand, the combination treatment of carbidopa/levodopa was originally developed by Watson Labs but the historical information by the FDA brings back to the approval of this combination therapy developed by Mayne Pharma in 1992.
Indication
Carbidopa is indicated with levodopa for the treatment of symptoms of idiopathic Parkinson disease, postencephalitic parkinsonism and symptomatic parkinsonism followed by carbon monoxide or manganese intoxication. The combination therapy is administered for the reduction of levodopa-driven nausea and vomiting. The product of carbidopa should be used in patients where the combination therapy of carbidopa/levodopa provide less than the adequate daily dosage. As well carbidopa can be used in patients where the dosages of carbidopa and levodopa require individual titration.
Associated Conditions
- Parkinson's Disease (PD)
- Parkinsonism post encephalitic
- Symptomatic Parkinson Disease
- Levodopa-driven nausea and vomiting
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/02/21 | Phase 2 | Withdrawn | |||
2021/02/08 | Phase 4 | Withdrawn | |||
2021/01/25 | Phase 4 | Completed | |||
2020/08/20 | Phase 2 | Recruiting | |||
2020/03/27 | Phase 1 | Completed | |||
2020/01/29 | Phase 1 | Recruiting | Daniel Claassen | ||
2019/06/27 | Phase 2 | Suspended | Jessica M D'Amico | ||
2019/03/25 | Phase 1 | Completed | |||
2018/07/03 | Phase 2 | UNKNOWN | |||
2018/04/12 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 71610-269 | ORAL | 25 mg in 1 1 | 1/4/2019 | |
| Mylan Pharmaceuticals Inc. | 0378-0088 | ORAL | 25 mg in 1 1 | 10/25/2022 | |
| Almatica Pharma LLC | 52427-805 | ORAL | 12.5 mg in 1 1 | 12/31/2019 | |
| Aurobindo Pharma Limited | 59651-458 | ORAL | 25 mg in 1 1 | 12/13/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-202 | ORAL | 25 mg in 1 1 | 6/22/2016 | |
| TruPharma, LLC | 52817-392 | ORAL | 25 mg in 1 1 | 4/8/2023 | |
| Almatica Pharma LLC | 52427-834 | ORAL | 37.5 mg in 1 1 | 12/31/2019 | |
| A-S Medication Solutions | 50090-3419 | ORAL | 25 mg in 1 1 | 9/30/2020 | |
| Radha Pharmaceuticals Inc | 77771-461 | ORAL | 50 mg in 1 1 | 4/25/2025 | |
| Zydus Lifesciences Limited | 70771-1355 | ORAL | 25 mg in 1 1 | 10/13/2022 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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