Neither Food nor the Use of Sprinkle Delivery Impacts the Oral Bioavailability (BA) of a Novel Extended-Release (XR) Formulation of Lacosamide
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 (Capsulefa) in fasted (fa) state, lacosamide XR 200 mg capsule (Capsulefe) in fed (fe) state, and lacosamide XR 200 mg capsule sprinkle (Sprinklefa) in fasted state were administered. Subjects then entered a washout period where samples and safety profiles were collected. The PK parameters evaluated include Cmax, (AUC0-t), and (AUC0-∞). 90% confidence intervals (CI) for the geometric least square mean ratios for Cmax, AUC0-t, and AUC0-∞ were calculated. Safety and tolerability were assessed at regular intervals.
Results:
17 subjects were considered for Capsulefa/Capsulefe analysis, and 18 were considered for Capsulefa/Sprinklefa analysis. The results for Capsulefa/Capsulefe and Capsulefa/Sprinklefa fell within the 90% CI range for Cmax, (AUC0-t), and (AUC0-∞), 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.
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