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Upsher-Smith announced the results of a study comparing the bioequivalence of Qudexy XR (topiramate) extended-release capsules when opened and sprinkled onto soft food compared to intact capsules. The research was presented at the 67th American Academy of Neurology’s (AAN) Annual Meeting in Washington, D.C.
The Phase 1, randomized, single-dose crossover study (n=36) sought to evaluate an alternative administration method of Qudexy XR by comparing pharmacokinetic parameters when the drug was administered as an intact capsule vs. opening the capsule and sprinkling the beads on to soft food. AUC and Cmax were bioequivalent between the Qudexy XR beads sprinkled onto soft food and the intact capsule and the median Tmax was between 10–14 hours. Qudexy XR beads were successfully passed through >/= 14 French G-/J-tubes in separate in vitro experiments.
RELATED: FDA Expands Qudexy XR Monotherapy Age Range
Qudexy XR is indicated as initial monotherapy in patients aged ≥10 years with partial onset (POS) seizures or primary generalized tonic-clonic seizure (PGTC) seizures and as adjunctive therapy in patients aged ≥2 years with POS, PGTC, or seizures associated with Lennox-Gastaut syndrome. It is approved to be swallowed whole or opened and sprinkled on soft food.
For more information call (800) 654-2299 or visit QudexyXR.com.
