Aptiom (eslicarbazepine acetate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved November 2013

Specific Treatments:

partial-onset seizures

Therapeutic Areas

Find Related Trials for The Following Conditions

General Information

Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown.

Aptiom is specifically indicated as adjunctive treatment for partial-onset seizures.

Aptiom is supplied as a tablet for oral administration. The recommended initial dose is 400 mg once daily. After one week, increase dosage to 800 mg once daily (recommended maintenance dosage). Maximum recommended maintenance dosage is 1200 mg once daily (after a minimum of one week at 800 mg once daily).

Clinical Results

FDA Approval
The FDA approval of Aptiom was based on three randomized, double-blind, placebo-controlled, multicenter trials in adults with epilepsy (Studies 1, 2, and 3). Enrolled subjects had partial-onset seizures with or without secondary generalization and were not adequately controlled with 1 to 3 concomitant AEDs. Studies 1 and 2 compared dosages of Aptiom 400, 800, and 1200 mg once daily with placebo. Study 3 compared dosages of Aptiom 800 and 1200 mg once daily with placebo. In all three trials, following an 8­week Baseline Phase, which established a baseline seizure frequency, subjects were randomized to a treatment arm. The trials consisted of a treatment period consisting of an initial titration phase (2 weeks), and a subsequent maintenance phase (12 weeks). The specific titration schedule differed amongst the three studies. Thus, subjects were started on a daily dose of 400 mg or 800 mg and subsequently increased by 400 mg/day following one or two weeks, until the final daily target dose was achieved. The primary endpoint was the standardized seizure frequency during the Maintenance Phase over 28 days. The Aptiom treatment at 400 mg/day , in Studies 1 and 2, did not show significant treatment effect. A statistically significant effect was observed with Aptiom treatment at doses of 800 mg/day in Studies 1 and 2 but not in Study 3, and at doses of 1200 mg/day in all three studies.

Side Effects

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

  • dizziness
  • somnolence
  • nausea,
  • headache
  • diplopia
  • vomiting
  • fatigue
  • vertigo
  • ataxia
  • blurred vision
  • tremor

Mechanism of Action

Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown.

Literature References

Elger C, Halász P, Maia J, Almeida L, Soares-da-Silva P; BIA-2093-301 Investigators Study Group Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia 2009 Mar;50(3):454-63.

Additional Information

For additional information regarding Aptiom or partial onset seizures, please visit the Aptiom web page.