METHODS FOR DELIVERING A DRUG TO A HOSPITAL PATIENT FOR SHORT-TERM USE WHILE MINIMIZING LONG-TERM USE OF THE DRUG

• US 20130005772A1
• Filed: 07/03/2012
• Published: 01/03/2013
• Est. Priority Date: 05/16/2008
• Status: Active Grant

• Current Assignee: Merck Sharp & Dohme LLC (Merck & Co., Inc.)
• Original Assignee: Adolor Corporation (Merck & Co., Inc.)
• Inventors: MAURER, George Raymond, JONES, Robert Barnett
• Granted Patent: US 8,645,160 B2
• Time in Patent Office: Days
• US Class Current: 514/331
• CPC Class Codes: A61K 31/451 having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

Novel methods for delivering a drug to hospital patients for short-term in-hospital use while minimizing long-term use of the drug. Embodiments are provided in which hospitals are identified which may be eligible to treat patients, for example, perform certain types of surgery, and which have measures in place to limit use of the drug to short-term use. The identified hospitals are preferably registered in a storage medium, including computer readable storage media, and may be authorized to receive the shipments of the drug. The received drug may then be dispensed to the patient.

Claims

1-8. -8. (canceled)

9. A method of treating a subject undergoing abdominal surgery, comprising orally administering to the subject a composition comprising about 12 mg of alvimopan less than one day prior to surgery followed by administering the alvimopan composition to the subject twice daily beginning the day after surgery, wherein the method is carried out in a hospital that has acknowledged that:

(i) hospital staff who prescribe, dispense or administer the alvimopan composition have been provided education materials on the need to limit the use of the alvimopan composition to short-term, inpatient use;

(ii) the subject will not receive more than 15 total doses of the alvimopan composition; and

(iii) the alvimopan composition will not be dispensed to the subject after being discharged from the hospital.

10. The method of claim 9, wherein the alvimopan is administered to the subject for no more than 7 days following the surgery.