‘Bioequivalence’ shown for generic lamotrigine
medwireNews: The EQUIGEN trial shows that switching to and between generic versions of lamotrigine does not affect the plasma levels achieved by patients with epilepsy.
As reported in The Lancet Neurology, four different generic lamotrigine products achieved bioequivalence when given to 35 epilepsy patients for 14 days each.
Michael Privitera (University of Cincinnati Medical Center, Ohio, USA) and study co-authors gave the patients doses in line with the branded drug dose they were taking at enrolment and assigned them to take the generic products in a randomised, crossover fashion.
When the patients switched to and between generic products, it was 90% certain that the maximum plasma concentrations and areas under the curves achieved with one product were never more than 20% below or 25% above those achieved with another.
In an accompanying commentary, Emilio Perucca (University of Pavia and C. Mondino National Neurological Institute, Italy) says the study “provides strong evidence that, at least for lamotrigine, concerns about generic substitution are largely misplaced.”
He describes the data as “quite reassuring”, and believes that “organisations with a negative attitude to generic antiepileptic drug substitution should consider reviewing their position.”
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