FELBAMATE
Felbamate is an antiepileptic agent reserved for patients with severe epilepsy who have responded inadequately to alternative treatments. Due to the substantial risk of apl
How FELBAMATE Works
The precise mechanism by which felbamate exerts its anticonvulsant activity is unknown, though it demonstrates properties similar to other anti-epileptic drugs in animal models. It functions as an antagonist at the strychnine-insensitive glycine recognition site of the NMDA receptor-ionophore complex. This interaction may help reduce seizure spread and increase the seizure threshold to prevent epileptic activity. The drug's primary metabolites are either inactive or weakly active and do not contribute significantly to its therapeutic effect.
Details
- Status
- Prescription
- First Approved
- 2011-09-13
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION
FELBAMATE Approval History
What FELBAMATE Treats
3 indicationsFELBAMATE is approved for 3 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epilepsy
- Partial Seizures
- Lennox-Gastaut Syndrome
FELBAMATE Boxed Warning
WARNING 1. APLASTIC ANEMIA THE USE OF FELBAMATE ORAL SUSPENSION, USP IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE ORAL SUSPENSION SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS ). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBAMATE ORAL SUSPENSION WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HE...
WARNING 1. APLASTIC ANEMIA THE USE OF FELBAMATE ORAL SUSPENSION, USP IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE ORAL SUSPENSION SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS ). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBAMATE ORAL SUSPENSION WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION. AMONG FELBAMATE TREATED PATIENTS, APLASTIC ANEMIA (PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED OF HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE MORE THAN A 100 FOLD GREATER THAN THAT SEEN IN THE UNTREATED POPULATION (I.E., 2 TO 5 PER MILLION PERSONS PER YEAR). THE RISK OF DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20 TO 30%, BUT RATES AS HIGH AS 70% HAVE BEEN REPORTED IN THE PAST. THERE ARE TOO FEW FELBAMATE ASSOCIATED CASES, AND TOO LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE SYNDROME'S INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE FACTORS, IF ANY, THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS AT GREATER OR LESSER RISK. IN MANAGING PATIENTS ON FELBAMATE ORAL SUSPENSION, IT SHOULD BE BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBAMATE ORAL SUSPENSION FOR SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBAMATE EXPOSED PATIENTS FOR WHOM DATA ARE AVAILABLE HAS RANGED FROM 5 TO 30 WEEKS). HOWEVER, THE INJURY TO BONE MARROW STEM CELLS THAT IS HELD TO BE ULTIMATELY RESPONSIBLE FOR THE ANEMIA MAY OCCUR WEEKS TO MONTHS EARLIER. ACCORDINGLY, PATIENTS WHO ARE DISCONTINUED FROM FELBAMATE ORAL SUSPENSION REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD AFTERWARDS. IT IS NO
FELBAMATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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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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.
FELBAMATE FDA Label Details
Indications & Usage
FELBAMATE is indicated for the treatment of Epilepsy; Partial Seizures; Lennox-Gastaut Syndrome.
WARNING 1. APLASTIC ANEMIA THE USE OF FELBAMATE ORAL SUSPENSION, USP IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE ORAL SUSPENSION SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN L...
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FELBATOL
Full clinical data, patents, trials, and competitive landscape for felbamate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.