Patent ID: 9301934
Filing Date: 2016-04-05
CPC Classification: A61K,A61P

Claim Text:
1. A method for administering a therapeutically effective amount of a daily dose of about 300 mg to about 2000 mg of acamprosate to a subject suffering from alcohol dependence, comprising administering to the subject acamprosate or a pharmaceutically acceptable salt thereof dispersed in a gastric retained dosage form to the subject in which a fed mode has been induced and wherein the dosage form comprises a single polymer matrix comprising at least one swellable hydrophilic polymer that swells in a dimensionally unrestrained manner by imbibing water to increase its size to promote gastric retention of the dosage form in the stomach of the subject, wherein upon contact with aqueous fluid, at least about 80% of the acamprosate in the extended release portion of the dosage form is released by the dosage form over a period of at least about 5 hours, and wherein upon administration to the subject, the gastric retained dosage form provides a mean AUC of plasma acamprosate which is at least 50% greater than the mean AUC of plasma acamprosate provided by an immediate release (IR) dosage form or pharmaceutically acceptable salt thereof equal to or more than the dose of acamprosate in the gastric retained dosage form.