Clinical efficacy and prospects for the use of dibufelon in focal epilepsy (literature review, clinical case)

Epilepsy remains a difficult disease to overcome. One of the modern and promising areas in the search for new strategies for the treatment of difficult-to-treat forms of epilepsy is the combination of AEDs with antioxidants that affect the pathogenetic aspects of this disease. In 2021, PIK-PHARMA launched a new original drug for the treatment of epilepsy on the Russian market with the international generic name “fenosanoic acid” (FA) — dibufelon.

AIM: To evaluate the clinical efficacy and prospects of dibufelon using data from the literature review and clinical observation

MATERIALS AND METHODS. Study design — analytical review of the scientific literature. Subject of the study — focal epilepsy. Subject of the study was the clinical efficacy and prospects for the use of FA. The clinical example shows the effects of the use of dibufelon in seizure relapses.

RESULTS. In the study of the pharmacological properties of the drug, it was found that FA is rapidly absorbed from the gastrointestinal tract into the systemic circulation, remains long enough in the human body despite its high total clearance, and also penetrates well into organs and tissues. The study of the tissue availability of FA confirmed its entry into the brain as the zone of realisation of the anticonvulsant effect. Simultaneous administration of FA and valproic acid did not significantly affect their pharmacokinetic parameters.

According to the results of the clinical trial of the drug, a reduction in seizure frequency of at least 50 % from baseline was observed in 41 % of patients; the frequency of secondary generalised seizures decreased by an average of 75 %. A clinical example of the addition of dibufelon to a relapse of seizures showed good tolerability and efficacy of the drug.

CONCLUSION. Experience with the use of dibufenol in clinical practise has shown that, taking into account its complex antiepileptic and antioxidant effects, it can be optimally used as an adjunctive therapy in seizure relapses.

Dibufenol is a new antiepileptic drug with an original mechanism of action, efficacy in add-on therapy for focal epilepsy and a favourable tolerability profile.

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