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. 2025 Oct 11.
doi: 10.1007/s10072-025-08563-3. Online ahead of print.

Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study

Giuseppe Salafica  1 , Diana Tilenni  1 , Attilio Vinaccia  1 , Giovanni Tripepi  2 , Chiara Martellino  1 , Salvatore Maria Lima  3 , Giorgia Atanasio  1 , Fabio Lamanna  1 , Orazio Pardeo  1 , Mariangela Panebianco  4 , Angelina Laganà  1 , Angelo Labate  5
Affiliations

Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study

Giuseppe Salafica et al. Neurol Sci. .

Abstract

Purpose: Lacosamide (LCS) is a third-generation antiseizure medication (ASM) approved for focal-onset seizures and generalized epilepsy. Although the branded formulation, Vimpat®, has shown efficacy and safety, the introduction of generic versions, such as Stutan®, raises concerns about clinical equivalence, especially considering the potential for therapeutic fluctuations that could result in breakthrough seizures or adverse events. This study aimed to compare the real-world efficacy, safety and tolerability of branded lacosamide (Vimpat®) versus its generic counterpart (Stutan®) in patients with focal or generalized epilepsy.

Methods: A multicenter, retrospective, observational study was conducted at two epilepsy centers in Southern Italy. Sixty adult patients were included and divided into two groups: Group A (n = 30) received branded LCS and Group B (n = 30) received the generic formulation. Data were collected at treatment initiation (T0) and the first follow-up (T1), including seizure frequency, adverse events and dose adjustments. The primary outcome was the responder rate (≥ 50% reduction in seizure frequency), with secondary outcomes including seizure freedom, adverse events and dose changes.

Results: Baseline characteristics were similar between groups. The average daily LCS dose was significantly higher in the Vimpat® group (275 ± 121 mg) compared to the Stutan® group (168 ± 89 mg, p < 0.001). Despite this, efficacy outcomes were comparable, with 60.0% of patients in Group A and 43.3% in Group B achieving a ≥ 50% seizure reduction (p = 0.08). Adverse events were mild or moderate.

Conclusions: In this real-world setting, generic LCS (Stutan®) demonstrated comparable efficacy, safety and tolerability to Vimpat®, supporting its clinical use as a valid alternative in epilepsy management.

Keywords: Epilepsy; Generic formulation; Lacosamide; Real-world study.

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Conflict of interest statement

Declarations. Consent to participate: Informed consent was obtained from all individual participants included in the study. Ethical statement: Not applicable. Conflict of interest statement: The authors declare that there are no conflicts of interest associated with this study. No financial or personal relationships have influenced the design, execution, or reporting of the research.

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