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ObjectiveEvaluate the pharmacokinetics (PK), safety, and tolerability of single doses of once‐daily USL255, Qudexy XR (topiramate) extended‐release capsules, over a wide dosing range.
MethodsTwo single‐dose, phase I studies in healthy adults were used to evaluate the PK profile and maximum tolerated dose (MTD) of USL255 from 25–1,400 mg. Standard PK parameters assessed included area under the plasma...
ObjectiveTo evaluate the efficacy and safety of USL255, Qudexy™XR (topiramate) extended‐release capsules, as an adjunctive treatment for refractory partial‐onset seizures (POS) in adults taking one to three concomitant antiepileptic drugs.
MethodsIn this global phase III study (PREVAIL; NCT01142193), 249 adults with POS were randomized 1:1 to once‐daily USL255 (200 mg/day) or placebo. The primary...
PurposeAlthough topiramate is widely prescribed for epilepsy and migraine, there is no intravenous product. We have developed an injectable topiramate formulation in which the drug is solubilized in a cyclodextrin matrix, Captisol® (Ligand Pharmaceuticals, Inc., La Jolla, CA). Our long‐term goal is to evaluate intravenous topiramate for the treatment of neonatal seizures. Prior to studies in newborns,...
PurposeAlthough oral topiramate (TPM) products are widely prescribed for migraines and epilepsy, injectable TPM is not available for human use. We have developed a solubilized TPM formulation using a cyclodextrin matrix, Captisol with the long‐term goal of evaluating its safety and efficacy in neonatal seizures. This study in healthy adult volunteers was performed as required by the U.S. Food and...
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