Comment on the Formulation of Intravenous Topiramate for the Treatment of Status Epilepticus

The recent review by Loscher and Trinka provides a compelling rationale for the development of an intravenous (IV) topiramate (TPM) formulation for the treatment of status epilepticus (SE) [ [1] Löscher W. Trinka E. The potential of intravenous topiramate for the treatment of status epilepticus. Epilepsy Behav. 2023; 109032 Google Scholar ]. The paper includes a comparison of a formulation using an alkalinizing excipient, meglumine, to a formulation containing sulfobutylether-β-cyclodextrin (SBE-β-CD, Captisol®). Captisol® is used for solubilization and stabilization in numerous drug products approved by the FDA and EMA, including those intended for children. In their article, the authors make several statements regarding orphan drug status, Captisol® exposure, safety, and pediatric use of Captisol®, which warrant clarification.