Generic Lacosamide Shows Comparable Efficacy to Branded Version in Epilepsy Treatment

Strategic Insights -

A recent study has found that generic lacosamide (Stutan) has comparable efficacy, safety, and tolerability to its branded counterpart (Vimpat) in patients with focal or generalized epilepsy. The study, conducted at two epilepsy centers in Southern Italy, involved 60 adult patients who were divided into two groups: one receiving the branded formulation and the other receiving the generic version. The research concluded that the generic lacosamide demonstrated comparable efficacy, safety, and tolerability to the branded version, supporting its clinical use as a valid alternative in epilepsy management.

Key Takeaways:

  • The study involved 60 adult patients with focal or generalized epilepsy, who were divided into two groups: one receiving the branded lacosamide (Vimpat) and the other receiving the generic version (Stutan).
  • The average daily lacosamide dose was significantly higher in the Vimpat group (275 ± 121 mg) compared to the Stutan group (168 ± 89 mg, p = 0.01).
  • The primary outcome was the responder rate (50% reduction in seizure frequency), with secondary outcomes including seizure freedom, adverse events, and dose changes.
  • The study was a multicenter, retrospective, observational study conducted at two epilepsy centers in Southern Italy.
  • The study found that the generic lacosamide demonstrated comparable efficacy, safety, and tolerability to the branded version.
  • The study has been peer-reviewed and published in the journal Neurological Sciences.

Statistics:

  • 60 adult patients were included in the study.
  • 30 patients received the branded lacosamide (Vimpat) and 30 patients received the generic version (Stutan).
  • The average daily lacosamide dose was 275 ± 121 mg in the Vimpat group and 168 ± 89 mg in the Stutan group, with a significant difference (p = 0.01).
  • 50% reduction in seizure frequency was the primary outcome, with 30 (50%) patients in the Vimpat group and 25 (41.7%) patients in the Stutan group achieving this outcome.
  • The study had a follow-up period of at least 6 months.

Sources:

  • NewsRx. University of Messina Reports Findings in Epilepsy (Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study). Health & Medicine Week. October 24, 2025; p 8485.
  • Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study. Neurological Sciences, 2025.
  • Neurological Sciences can be contacted at: Springer-verlag Italia Srl, Via Decembrio, 28, Milan, 20137, Italy. (Springer - www.springer.com; Neurological Sciences - www.springerlink.com/content/1590-1874/)