NEURONTIN
Neurontin (gabapentin) is indicated for the management of postherpetic neuralgia in adult patients. It is also approved as an adjunctive therapy for the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients three years and older with epilepsy. This medication serves a dual role as a treatment for specific neuropathic pain and as a supplemental therapy for seizure management.
How NEURONTIN Works
The precise mechanisms by which gabapentin exerts its analgesic and antiepileptic effects are unknown. Although the drug is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA), it does not interact with GABA binding, uptake, or degradation. Gabapentin binds with high affinity to the α2δ subunit of voltage-activated calcium channels. The specific relationship between this binding activity and the drug's therapeutic outcomes has not been established.
Details
- Status
- Prescription
- First Approved
- 1993-12-30
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, CAPSULE
NEURONTIN Approval History
What NEURONTIN Treats
3 indicationsNEURONTIN is approved for 3 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postherpetic Neuralgia
- Epilepsy
- Partial Onset Seizures
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEURONTIN FDA Label Details
ProIndications & Usage
FDA Label (PDF)NEURONTIN ® is indicated for: • Management of postherpetic neuralgia in adults • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy NEURONTIN is indicated for: • Postherpetic neuralgia in adults • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.