Overview
Topiramate is a anti-epileptic drug used to manage seizures and prevent migraines. It was initially approved by the FDA in 1996. In 2004, topiramate was approved for the prevention of migraine in adults. Since 2012, the extended-release formulation has been approved in combination with phentermine for chronic weight management therapy in adults. Characteristics that distinguish topiramate from other antiepileptic drugs are a monosaccharide chemical structure containing a sulfamate, and 40% of its mass accounted for by oxygen. Interestingly, topiramate was discovered by chance when attempts were made to formulate a novel antidiabetic drug.
Background
Topiramate is a anti-epileptic drug used to manage seizures and prevent migraines. It was initially approved by the FDA in 1996. In 2004, topiramate was approved for the prevention of migraine in adults. Since 2012, the extended-release formulation has been approved in combination with phentermine for chronic weight management therapy in adults. Characteristics that distinguish topiramate from other antiepileptic drugs are a monosaccharide chemical structure containing a sulfamate, and 40% of its mass accounted for by oxygen. Interestingly, topiramate was discovered by chance when attempts were made to formulate a novel antidiabetic drug.
Indication
Topiramate is indicated for the following conditions: 1)Monotherapy for partial onset or primary generalized tonic-clonic seizures for patients 2 years of age and above 2)Adjunctive therapy for partial onset seizures or primary generalized tonic-clonic seizures for both adult and pediatric patients above 2 years old 3)Adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients above 2 years of age 4)Prophylaxis of migraine in children 12 years of age and older and adults. Topiramate is also used off-label as an adjunct therapy for weight management and for mood disorders.
Associated Conditions
- Alcohol Dependency
- Epilepsy, Primary Generalized Tonic-Clonic Seizures
- Generalized Tonic-Clonic Seizures
- Lennox-Gastaut Syndrome
- Migraine
- Moods Disorders
- Partial-Onset Seizures
- Seizures
- Weight
Research Report
Topiramate: A Comprehensive Pharmacological and Clinical Review
1. Introduction to Topiramate
Overview and Therapeutic Class
Topiramate is a broad-spectrum antiepileptic drug (AED) widely utilized in the management of various seizure disorders. Beyond its anticonvulsant properties, topiramate is also established for the prophylaxis of migraine headaches and, as a component of a combination product, for chronic weight management.[1] It is classified as a small molecule drug.[1] The therapeutic versatility of topiramate is attributed to its multiple, distinct mechanisms of action, which differentiate it from many other AEDs that often target a single pathway.[1] This multifaceted pharmacological profile allows topiramate to modulate neuronal excitability through several complementary pathways, contributing to its efficacy in conditions characterized by neuronal hyperexcitability.
Historical Background and Discovery
Topiramate first received approval from the U.S. Food and Drug Administration (FDA) in 1996 for the treatment of epilepsy.[1] Its indications were later expanded in 2004 to include the prevention of migraine headaches in adult populations.[1] A significant development occurred in 2012 when an extended-release formulation of topiramate, in combination with phentermine (marketed as Qsymia®), was approved by the FDA for chronic weight management in adults.[1]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
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2008/09/16 | Phase 1 | Completed | |||
2008/09/03 | Phase 1 | Completed | |||
2008/08/19 | Phase 2 | Terminated | |||
2008/08/11 | Not Applicable | Withdrawn | |||
2008/07/31 | Phase 4 | Completed | Federal University of São Paulo | ||
2008/06/19 | Phase 1 | Completed | |||
2008/05/28 | Phase 2 | Completed | |||
2008/04/01 | Phase 1 | Completed | |||
2008/04/01 | Phase 1 | Completed | |||
2008/04/01 | Phase 1 | Completed |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
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ORAL | 200 mg in 1 1 | 2023/05/23 | 61919-823 | ||
ORAL | 50 mg in 1 1 | 2022/11/17 | 53002-1547 | ||
ORAL | 100 mg in 1 1 | 2023/07/26 | 16571-707 | ||
ORAL | 25 mg in 1 1 | 2023/07/19 | 27241-227 | ||
ORAL | 25 mg in 1 1 | 2022/03/14 | 71335-0548 | ||
ORAL | 50 mg in 1 1 | 2023/09/28 | 70771-1657 | ||
ORAL | 25 mg in 1 1 | 2023/09/28 | 70771-1656 | ||
ORAL | 200 mg in 1 1 | 2023/09/28 | 70771-1660 | ||
ORAL | 150 mg in 1 1 | 2023/09/28 | 70771-1659 | ||
ORAL | 25 mg in 1 1 | 2023/03/15 | 61919-883 |
EMA Approved Products
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HSA Approved Products
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NMPA Approved Products
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Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
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HK-54628 | trenton-boma ltd | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2006/08/11 | |
HK-65187 | i & c (hong kong) limited | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2017/06/09 | |
HK-65188 | i & c (hong kong) limited | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2017/06/09 |
TGA Approved Products
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