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Onfi (clobazam)

Company: Lundbeck
Approval Status: Approved October 2011
Treatment for: seizures associated with Lennox-Gastaut syndrome
Areas: Neurology & Nervous System; Pediatrics

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

Onfi (clobazam) is am antiepileptic drug of the benzodiazepine class. The exact mechanism of action for clobazam is not fully understood but is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABAA receptor.

Onfi is specifically indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older.

Onfi is supplied as a a tablet for oral administration. The tablets can be administered whole, or crushed and mixed in applesauce. Onfo tablets should be administered in divided doses twice daily. Patients should be dosed according to body weight:
30kg Body Weight and Under:
Starting Dose: 5mg
Starting Day 7: 10mg
Starting Day 14: 20mg
30kg Body Weight and Above:
Starting Dose: 10mg
Starting Day 7: 20mg
Starting Day 14: 40mg


Clinical Results

FDA Approval
The FDA approval of Onfi was based on two multicenter controlled studies (Study 1 and Study 2).
Study 1
This randomized, double-blind, placebo-controlled study enrolled 238 subjects who were divided into two weight groups and administered the doses as outlined above. The primary efficacy measure was the percent reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic) from the four-week baseline period to 12-week maintenance period. The pre-dosing baseline mean weekly drop seizure frequency was 98, 100, 61, and 105 for the placebo, low-, medium-, and high-dose groups, respectively. All dose groups of Onfi were statistically superior (p=0.05) to the placebo group. This effect appeared to be dose dependent.
Study 2
This randomized, double-blind comparison study enrolled 68 subjects and evaluated high- and low-dose Onfi. A statistically significantly greater reduction in seizure frequency was observed in the high-dose group compared to the low-dose group (median percent reduction of 93% vs 29%; p<0.05).


Side Effects

Adverse events associated with the use of Onfi may include, but are not limited to, the following:

  • somnolence
  • sedation
  • drooling
  • constipation
  • cough
  • urinary tract infection
  • aggression
  • insomnia
  • dysarthria
  • fatigue


Mechanism of Action

Onfi (clobazam) is am antiepileptic drug of the benzodiazepine class. The exact mechanism of action for clobazam, a 1,5-benzodiazepine, is not fully understood but is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABAA receptor.


Literature References

Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA; On behalf of the OV-1012 Study Investigators Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology 2011 Oct 11;77(15):1473-1481


Additional Information

For additional information regarding Onfi or seizures associated with Lennox-Gastaut syndrome, please visit the Onfi web page.




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Onfi Drug Information

The Onfi drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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