# US 2021/0330652 A1 · Compositions comprising cytisine in the treatment and/or prevention of addiction in subjects in need thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330652 A1 - Document ID: US20210330652A1 - Status: Published application - Kind: A1 - Application number: 17/366,497 - Filed: 2021-07-02 - Published: 2021-10-28 - Earliest claimed: 2019-09-12 - Assignees: Achieve Life Sciences, Inc. - Applicants: Achieve Life Sciences, Inc. - Inventors: Cindy A. Jacobs; Daniel F. Cain; Anthony Clarke - Web page: https://patentgrep.com/patent/US20210330652A1 ## CPC - A61K 31/439: the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46) - A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine - A61P 25/34: Tobacco-abuse - 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 Methods of treatment of addiction and/or dependence, methods of promoting cessation of various addictions, such as smoking and/or vaping, and methods of promoting a reduction in various addictions, such as smoking and/or vaping, uses of cytisine as an addiction cessation treatment, and dosage regimens for the foregoing are provided. ## Claims ### Claim 1 A method of treating a nicotine dependence, treating a nicotine addiction, promoting cessation of smoking and/or vaping, and/or promoting a reduction in smoking and/or vaping in a subject in need thereof, the method comprising administering cytisine provided in a unit dose of 3.0 mg, 1.5 mg, or 1.0 mg of cytisine three times daily to the subject. ### Claim 2 (depends on 1) The method of claim 1, wherein the subject experiences no adverse events after receiving the cytisine treatment. ### Claim 3 (depends on 2) The method of claim 2, wherein the adverse event is selected from the group consisting of an upper respiratory tract infection (URTI), abnormal dreams, nausea, insomnia, headache, fatigue, and constipation. ### Claim 4 (depends on 3) The method of claim 3, wherein the subject experiences no nausea after receiving the cytisine treatment. ### Claim 5 (depends on 1) The method of claim 1, wherein cytisine is administered for about 6 weeks or for about 12 weeks. ### Claim 6 (depends on 1) The method of claim 1, wherein the unit dose of cytisine comprises (a) two tablets, each tablet either containing 1.5 mg or 3.0 mg of cytisine, (b) a single tablet either containing 1.5 mg or 3.0 mg of cytisine, or (c) three tablets, each tablet containing 1.0 mg of cytisine. ### Claim 7 (depends on 1) The method of claim 1, wherein the subject is a refractory patient who has failed treatment with one or more nicotine addiction or smoking cessation treatments. ### Claim 8 (depends on 7) The method of claim 7, wherein the nicotine addiction or smoking cessation treatments are selected from nicotine replacement therapy (NRT), administration of bupropion, administration of varenicline, electronic cigarettes, vaping, and a combination thereof. ### Claim 9 (depends on 1) The method of claim 1, wherein the subject (a) smoked ten or more cigarettes per day prior to the administration of cytisine, (b) has expired air CO concentration of about 10 ppm or greater prior to the administration of cytisine, or (c) a combination of (a) and (b). ### Claim 10 (depends on 1) The method of claim 1, further comprising providing behavioral support to the subject. ### Claim 11 A method of treating of nicotine addiction in a subject in need thereof, the method comprising administering cytisine to the subject, wherein the subject is a refractory patient who has failed treatment with one or more nicotine addiction treatments. ### Claim 12 (depends on 11) The method of claim 11, wherein the nicotine addiction treatments comprise NRT, administration of bupropion, administration of varenicline, electronic cigarettes, vaping, or a combination thereof. ### Claim 13 (depends on 10) The method of claim 10, wherein cytisine is provided in a unit dose of about 1.0 mg to about 6.0 mg of cytisine three to six times daily to a subject in need thereof. ### Claim 14 (depends on 10) The method of claim 10, wherein cytisine is provided in a unit dose of 3.0 mg of cytisine three times daily to a subject in need thereof. ### Claim 15 (depends on 13) The method of claim 13, wherein the unit dose of cytisine comprises (a) two tablets, each tablet either containing 1.5 mg or 3.0 mg of cytisine, (b) a single tablet either containing 1.5 mg or 3.0 mg of cytisine, or (c) three tablets, each tablet containing 1.0 mg of cytisine. ### Claim 16 (depends on 15) The method of claim 15, wherein cytisine is administered for about 6 weeks or for about 12 weeks. ### Claim 17 (depends on 10) The method of claim 10, wherein the subject experiences no adverse events after receiving the cytisine treatment. ### Claim 18 (depends on 17) The method of claim 17, wherein the adverse event is selected from the group consisting of an URTI, abnormal dreams, nausea, insomnia, headache, fatigue, and constipation. ### Claim 19 (depends on 10) The method of claim 10, wherein the subject (a) smoked ten or more cigarettes per day prior to the administration of cytisine, (b) has expired air CO concentration of about 10 ppm or greater prior to the administration of cytisine, or (c) a combination of (a) and (b). ### Claim 20 A method of preventing smoking and/or vaping relapse in a subject in need thereof, the method comprising administering cytisine provided in a unit dose of (a) two tablets, each tablet either containing 1.5 mg or 3.0 mg of cytisine, (b) a single tablet either containing 1.5 mg or 3.0 mg of cytisine, or (c) three tablets, each tablet containing 1.0 mg of cytisine, three times daily to the subject. ### Claim 21 (depends on 20) The method of claim 20, wherein cytisine is administered for about 6 weeks or for about 12 weeks. ### Claim 22 (depends on 20) The method of claim 20, wherein the subject experiences no adverse events after receiving the cytisine treatment. ### Claim 23 (depends on 22) The method of claim 22, wherein the adverse event is selected from the group consisting of an URTI, abnormal dreams, nausea, insomnia, headache, fatigue, and constipation. ### Claim 24 (depends on 20) The method of claim 20, wherein the subject (a) smoked ten or more cigarettes per day prior to the administration of cytisine, (b) has expired air CO concentration of about 10 ppm or greater prior to the administration of cytisine, or (c) a combination of (a) and (b). ### Claim 25 (depends on 20) The method of claim 20, wherein the subject is a refractory patient who has failed treatment with one or more smoking cessation treatments. ### Claim 26 (depends on 25) The method of claim 25, wherein the smoking cessation treatments comprise NRT, administration of bupropion, administration of varenicline, electronic cigarettes, vaping, or a combination thereof. ### Claim 27 A method of preventing smoking and/or vaping relapse in a subject in need thereof, the method comprising administering cytisine to the subject, wherein the subject is a refractory patient who has failed treatment with one or more smoking cessation treatments selected from the group consisting of NRT, administration of bupropion, administration of varenicline, electronic cigarettes, vaping. ### Claim 28 (depends on 27) The method of claim 27, wherein the subject (a) smoked ten or more cigarettes per day prior to the administration of cytisine, (b) has expired air CO concentration of about 10 ppm or greater prior to the administration of cytisine, or (c) a combination of (a) and (b). ### Claim 29 (depends on 27) The method of claim 27, wherein the unit dose of cytisine comprises (a) two tablets, each tablet either containing 1.5 mg or 3.0 mg of cytisine, (b) a single tablet either containing 1.5 mg or 3.0 mg of cytisine, or (c) three tablets, each tablet containing 1.0 mg of cytisine, and wherein cytisine is administered for about 6 weeks or for about 12 weeks. ### Claim 30 (depends on 27) The method of claim 27, wherein the subject experiences no adverse events selected from the group consisting of an URTI, abnormal dreams, nausea, insomnia, headache, fatigue, and constipation after receiving the cytisine treatment.