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Background <p>Epilepsy is one of the most chronic neurological disorders worldwide. In 2023, the World Health Organization (WHO) estimates that approximately 50&#xa0;million individuals globally would be affected by epilepsy. Furthermore, it was suggested that as many as 70% of patients could experience a life without seizure if they received appropriate treatment. Lamotrigine (LTG) is one of the newer antiepileptic drugs. It has been globally marketed under the name Lamictal<sup>00AE</sup>. Due to the increasing demand for transformation between brand and generic products, this study aims to evaluate the product safety and efficacy on liver enzymes, as well as the behavioral effects and pharmacokinetics of lamotrigine, specifically the brand Lamictal<sup>00AE</sup> and its generics available in the Saudi market.</p> Methods <p>Male albino mice with an average weight of 24&#xa0;g will be randomly divided into groups (<i>n</i> = 6) for pharmacokinetic study, liver enzyme analysis, and behavioral evaluation of brand Lamictal<sup>00AE</sup> and generics. One-way ANOVA and Bonferroni’s post hoc test will be used to compare results in the different animal groups. Statistical significance p-values will be determined at <i>P</i> &lt; 0.05.</p> Results <p>The study found that generics had a significant difference PK parameters were compared to those of Lamictal<sup>00AE</sup>, which was mostly found in generics 1 and 2. Liver analysis revealed liver enzyme elevation in all generics compared to the brand Lamictal<sup>00AE</sup>, which was primarily pronounced in AST and GGT with generic 2, and an increase in ALT, ALP, and GGT was primarily found in generic 1. The behavioral study indicates higher seizure attacks in generics compared to the brand Lamictal<sup>00AE</sup>, with an increase in mortality rates mainly observed with generics 1 and 2.</p> Conclusions <p>This research finds that there is a significant difference in safety and efficacy between brand and generic lamotrigine products in terms of liver enzyme tests, behavioral analysis, and PK parameters. Future studies to evaluate lamotrigine brand and generic drugs in humans are recommended.</p>

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Comparative analysis of safety and efficacy between brand and generic lamotrigine products in the Saudi market

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月1日

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  • Haya Alotaibi,
  • Sarah Sulaiman Alenazi,
  • Sarah Alrubia,
  • Maria Arafah,
  • Nourah Alzoman,
  • Aliyah Almomen

摘要

Background

Epilepsy is one of the most chronic neurological disorders worldwide. In 2023, the World Health Organization (WHO) estimates that approximately 50 million individuals globally would be affected by epilepsy. Furthermore, it was suggested that as many as 70% of patients could experience a life without seizure if they received appropriate treatment. Lamotrigine (LTG) is one of the newer antiepileptic drugs. It has been globally marketed under the name Lamictal00AE. Due to the increasing demand for transformation between brand and generic products, this study aims to evaluate the product safety and efficacy on liver enzymes, as well as the behavioral effects and pharmacokinetics of lamotrigine, specifically the brand Lamictal00AE and its generics available in the Saudi market.

Methods

Male albino mice with an average weight of 24 g will be randomly divided into groups (n = 6) for pharmacokinetic study, liver enzyme analysis, and behavioral evaluation of brand Lamictal00AE and generics. One-way ANOVA and Bonferroni’s post hoc test will be used to compare results in the different animal groups. Statistical significance p-values will be determined at P < 0.05.

Results

The study found that generics had a significant difference PK parameters were compared to those of Lamictal00AE, which was mostly found in generics 1 and 2. Liver analysis revealed liver enzyme elevation in all generics compared to the brand Lamictal00AE, which was primarily pronounced in AST and GGT with generic 2, and an increase in ALT, ALP, and GGT was primarily found in generic 1. The behavioral study indicates higher seizure attacks in generics compared to the brand Lamictal00AE, with an increase in mortality rates mainly observed with generics 1 and 2.

Conclusions

This research finds that there is a significant difference in safety and efficacy between brand and generic lamotrigine products in terms of liver enzyme tests, behavioral analysis, and PK parameters. Future studies to evaluate lamotrigine brand and generic drugs in humans are recommended.