# US 2014/0155424 A1 · Naltrexone long acting formulations and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0155424 A1 - Document ID: US20140155424A1 - Status: Published application - Kind: A1 - Application number: 13/871,534 - Filed: 2013-04-26 - Published: 2014-06-05 - Earliest claimed: 2004-04-22 - Assignees: Alkermes, Inc. - Inventors: Elliot Ehrich - Web page: https://patentgrep.com/patent/US20140155424A1 ## CPC - A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 31/485: Morphinan derivatives, e.g. morphine, codeine - A61P 25/32: Alcohol-abuse - A61K 9/1641: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The inventions described herein arose from unexpected discoveries made during clinical trials with a long acting formulation of naltrexone. As such, the invention includes a method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising naltrexone and to the use of naltrexone in the manufacture of medicaments for use in such methods. ## Claims ### Claim 1 A method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising naltrexone to the individual wherein the serum AUC of naltrexone is at least about two times greater than that achieved by 50 mg/day oral administration. ### Claim 2 A method of treating an individual in need of naltrexone comprising administering a long acting formulation in a dose comprising between about 160 and 240 mg of naltrexone or about 310 to about 480 mg of naltrexone. ### Claim 3 A method of increasing the days prior to occurrence of alcohol consumption in an individual in need of naltrexone comprising administering a long acting formulation comprising naltrexone, in the absence of co-administering alcohol, to an individual who has not abstained from alcohol within three days, such as five days, prior to the naltrexone administration. ### Claim 4 A method of treating an individual in need of naltrexone comprising administering a long acting formulation comprising naltrexone in a dosage between about 160 mg to about 480 mg naltrexone every four weeks for a period of about 24 weeks or more wherein the individual has not used oral naltrexone within five days, such as within ten days, before said administration. ### Claim 5 (depends on 1) The method of claim 1 wherein the long acting formulation releases naltrexone for a period of at least two weeks. ### Claim 6 (depends on 1) The method of claim 1 wherein the long acting formulation releases naltrexone for a period of about four weeks. ### Claim 7 (depends on 1) The method of claim 1 wherein the long acting formulation is administered in a dose of at least about 160 mg of naltrexone. ### Claim 8 (depends on 1) The method of claim 1 wherein the long acting formulation is administered in a dose between about 160 and 240 mg of naltrexone. ### Claim 9 (depends on 10) The method of claim 10 wherein the long acting formulation is administered in a dose of about 190 mg of naltrexone. ### Claim 10 (depends on 1) The method of claim 1 wherein the long acting formulation is administered in a dose between about 310 and 480 mg of naltrexone. ### Claim 11 (depends on 1) The method of claim 1 wherein the long acting formulation is administered over a period of about 24 week period or longer. ### Claim 12 (depends on 1) The method of claim 1 further comprising a second administration of a long acting formulation comprising naltrexone at least about 7 days, preferably at least about 14 days, more preferably at least about 21 days, such as about 28 days, after the first administration. ### Claim 13 (depends on 12) The method of claim 12 wherein the second long acting formulation is the same as the first long acting formulation. ### Claim 14 (depends on 1) The method of claim 1 wherein the individual is an individual afflicted by alcohol dependency, such as a heavy drinker. ### Claim 15 (depends on 1) The method of claim 1 wherein naltrexone is administered by injection, such as intramuscularly or subcutaneously. ### Claim 16 (depends on 1) The method of claim 1 wherein the long acting formulation comprises a polylactide polymer or a poly lactic acid polymer. ### Claim 17 (depends on 1) The method of claim 1 wherein the long acting formulation comprises a polylactide-co-glycolide polymer, such as a polymer which possesses a molecular weight of at least 100,000 daltons. ### Claim 18 (depends on 1) The method of claim 1 wherein the naltrexone is present in the long acting formulation at a concentration of about 35% by weight.