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Label indication TOPAMAX is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine… FDA label
Also known as Topamax®
Topiramate IR · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Topiramate IR followed by Topiramate ER | OTHER | Dosing with IR followed by dosing with ER |
| Name | Type | Description |
|---|---|---|
| Topiramate IR | DRUG | - |
| Topiramate ER | DRUG | - |
Inclusion Criteria: 1. Adult male or female patients with epilepsy on stable doses of topiramate. 2. Able to voluntarily provide written informed consent to participate in the study. 3. Use of an effective form of birth control if of child-bearing potential. Exclusion Criteria: 1. Diagnosis of st...
Top 9 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Xenon Pharmaceuticals Inc. | XENE | 4 | PHASE3 | Azetukalner |
| Praxis Precision Medicines, Inc. | PRAX | 5 | PHASE3 | Vormatrigine, Elsunersen |
| Rapport Therapeutics, Inc. | RAPP | 3 | PHASE3 | RAP-219 |
| Supernus Pharmaceuticals, Inc. | SUPN | 4 | PHASE2 | SPN-817, BIS-001ER |
| Biohaven Ltd. | BHVN | 3 | PHASE2 | BHV-7000 |
| Harmony Biosciences Holdings, Inc. | HRMY | 1 | PHASE3 | Clemizole |
| Jazz Pharmaceuticals Public Limited Company | JAZZ | 3 | PHASE1 | CBD-OS, Epidiolex |
| Bright Minds Biosciences Inc. | DRUG | 1 | PHASE2 | BMB-101 |
| uniQure N.V. | QURE | 1 | PHASE1 | AMT-260 |
Topiramate IR is an immediate-release formulation of topiramate being studied for epilepsy. Supernus Pharmaceuticals is developing it, and the clinical work recorded for this asset is in Phase 1. It is an investigational formulation rather than a newly approved product, and the epilepsy studies to date have involved adults aged 18 years and older.
Topiramate IR acts as an antagonist at AMPA and kainate glutamate receptors, with the target set including GRIA1, GRIA2, GRIA3, GRIA4, GRIK1 and GRIK5. These receptors mediate excitatory glutamate signaling in the central nervous system, and blocking them is the mechanism attributed to this small molecule in its epilepsy development program.
Supernus Pharmaceuticals, Inc., which trades on Nasdaq under the ticker SUPN, is the developer of Topiramate IR. The company is advancing the immediate-release formulation in epilepsy, with the clinical activity recorded for this asset conducted in the United States.
Topiramate IR is in Phase 1 development. One Phase 1 trial has been completed and no trials for this asset are currently active, so the program remains in early clinical development and is not an approved product.
Topiramate IR has been studied in NCT01114854, a completed Phase 1 conversion study comparing immediate-release and modified-release forms of topiramate in epilepsy. The trial enrolled 69 participants in the United States, included adults 18 years and older, and was an uncontrolled study without randomization or double blinding.