Abstract Details

Title Neither Food nor the Use of Sprinkle Delivery Impacts the Oral Bioavailability (BA) of a Novel Extended-Release (XR) Formulation of Lacosamide

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P9 - Poster Session 9 (11:45 AM-12:45 PM)

Poster/Presentation
Number 9-002

Objective The pharmacokinetic (PK) investigation of lacosamide XR capsules in this study aimed to shed light on the influence of food intake and sprinkle delivery on drug absorption.

Background While some antiseizure medications found that food has the potential to impact oral BA, lacosamide immediate-release tablets have demonstrated food does not affect the rate/extent of absorption. Lacosamide XR capsules allows for once-daily dosing, which may have practical clinical advantages with less fluctuations in plasma concentration at steady state.

Design/Methods This study was an open-label, balanced, randomized, single-dose, 3-treatment condition, 3-sequence, 3-period, crossover oral BA study. Lacosamide XR 200 mg capsule (Capsule_fa) in fasted (_fa) state, lacosamide XR 200 mg capsule (Capsule_fe) in fed (_fe) state, and lacosamide XR 200 mg capsule sprinkle (Sprinkle_fa) in fasted state were administered. Subjects then entered a washout period where samples and safety profiles were collected. The PK parameters evaluated include C_max, (AUC_0-t), and (AUC_0-∞). 90% confidence intervals (CI) for the geometric least square mean ratios for C_max,AUC_0-t,andAUC_0-∞ were calculated. Safety and tolerability were assessed at regular intervals.

Results 17 subjects were considered for Capsule_fa/Capsule_fe analysis, and 18 were considered for Capsule_fa/Sprinkle_fa analysis. The results for Capsule_fa/Capsule_fe and Capsule_fa/Sprinkle_fa fell within the 90% CI range for C_max, (AUC_0-t), and (AUC_0-∞), indicating food or sprinkle does not affect the absorption of lacosamide XR. One adverse event was reported. Based on safety assessments, all values and reports of all subjects were found to be within normal limits or clinically not significant.

Conclusions The PK parameters of lacosamide XR were compared when taken in the fasted, fed, and sprinkled states. Coadministration of lacosamide XR with a high-fat meal or the use of a sprinkle administration do not affect the overall exposure of lacosamide. Lacosamide XR capsules can be taken with or without meals and can be used as a sprinkle.

Authors/Disclosures
Marie Tan, MD (Aucta Pharmaceuticals, Inc.) PRESENTER	Dr. Tan has nothing to disclose.
Rong Li, PhD	Mrs. Li has nothing to disclose.

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