Lacosamide pharmaceutical composition and dosage form thereof

A dosage form of lacosamide comprising:

• an extended release (ER) portion comprising one or more extended release agents and a first portion of lacosamide or a pharmaceutically acceptable salt thereof, wherein the first portion of lacosamide or the pharmaceutically acceptable salt thereof and the one or more extended release agents are in a ratio ranging from about 15:1 to about 1:1 by weight, and
• optionally an immediate release (IR) portion comprising a second portion of lacosamide or a pharmaceutically acceptable salt thereof,
• wherein the total amount of lacosamide or a pharmaceutically acceptable salt thereof is at least 20% by weight in the dosage form;
• wherein the dosage form is configured so that, when administered orally once a day, is characterized by one or more of the following:
• (a) AUC0-3h is equal or more than 40% of a reference AUC0-3h resulting from a reference IR dosage form administered twice a day, wherein the amount of lacosamide or a pharmaceutically acceptable salt thereof in the reference IR dosage form is the same as the total amount of lacosamide or a pharmaceutically acceptable salt thereof in the dosage form;
• (b) AUC0-6h is equal or more than 60% of a reference AUC0-6h resulting from the reference IR dosage form administered twice a day;
• and
• (c) AUC12-24h ranging from about 80% to 125% of a reference AUC12-24h resulting from the reference IR dosage form administered twice a day.