MYSOLINE (primidone)
Mysoline (primidone) is an anti-epileptic agent indicated for the control of grand mal, psychomotor, and focal epileptic seizures. It can be administered as a monotherapy or used concomitantly with other anticonvulsant medications. The drug also serves as a therapeutic option for patients with grand mal seizures that have proven refractory to other anticonvulsant treatments.
How MYSOLINE Works
The specific mechanism of primidone’s antiepileptic action is not known, though it has been shown to raise seizure thresholds and alter seizure patterns in animal models. Primidone itself possesses anticonvulsant activity, as do its two metabolites, phenobarbital and phenylethylmalonamide (PEMA). Additionally, the PEMA metabolite serves to potentiate the anticonvulsant activity of phenobarbital.
Details
- Status
- Prescription
- First Approved
- 1954-03-08
- Routes
- ORAL
- Dosage Forms
- TABLET
MYSOLINE Approval History
What MYSOLINE Treats
4 indicationsMYSOLINE is approved for 4 conditions since its original approval in 1954. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Grand Mal Seizures
- Psychomotor Seizures
- Focal Seizures
- Epilepsy
MYSOLINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02008123 | 434350-2 | Ph 2 | withdrawn | Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant |
Active Pipeline
Ongoing clinical trials by development phase
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.
MYSOLINE FDA Label Details
Indications & Usage
FDA Label (PDF)MYSOLINE is indicated for the treatment of Grand Mal Seizures; Psychomotor Seizures; Focal Seizures; Epilepsy.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.