PHILADELPHIA—Among patients with epilepsy, a branded version of lamotrigine is bioequivalent to
two of the most disparate generic lamotrigine products,
according to trial results presented at the 69th Annual
Meeting of the American Epilepsy Society. In addition,
no patients in the prospective, multicenter trial were
outliers with differential pharmacokinetic reactions to
any of the products studied, researchers said.
Anecdotal reports of patients experiencing seizures
after switching versions of antiepileptic drugs (AEDs)
caused neurologists to question whether bioequivalence
testing performed in healthy subjects for the FDA translated to similar bioequivalence in patients with epilepsy
in real-world conditions.
To investigate this question, Michel Berg, MD, Professor of Neurology at the University of Rochester,
and colleagues conducted the Equivalence Among
Generic Antiepileptic Drugs (EQUIGEN) single-dose
study, a masked, replicate, sequence-randomized
pharmacokinetic trial in people with epilepsy on
concomitant AEDs.
Two other studies—the EQUIGEN chronic-dose
study and the Bioequivalence in Epilepsy Patients (BEEP)
study—also found that, in patients with epilepsy, generic lamotrigine products demonstrated bioequivalence to the branded product Lamictal. The EQUIGEN chronic-dose study results were presented at last
year’s American Epilepsy Society meeting. The BEEP
Are Generic and Branded Versions
of Lamotrigine Bioequivalent?
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continued on page 3
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