Title:  Methods to abate the use of tobacco by humans

United States Patent:  6,224,897

Assignee:  Novartis Consumer Health S.A. (Nyon, CH)

Filed:  September 29, 1998

The present invention is directed to patient-controlled, flexible-dosing methods of treatment utilizing transdermal nicotine patch devices, optionally with other nicotine delivery systems, to abate the use of tobacco in humans.

SUMMARY OF THE INVENTION

The present invention is directed to a patient-controlled method of treatment to abate tobacco use in humans. The method comprises:

(a) upon commencement of treatment, i.e. Day 1 of treatment, applying to the skin of a human at least one transdermal nicotine patch device (TNPD) comprising a total absorbable dosage of nicotine (TAND) effective to abate symptoms associated with withdrawal from nicotine (NWS), the TAND not to exceed a maximum amount effective to induce symptoms associated with excess dosing of nicotine (NES), and the TAND to be determined by the human,

(b) about 16 to about 24 hours after application of the TNPD applied in step (a), removing the TNPD applied in step (a) and applying to the skin of the human at least one TNPD comprising a TAND effective to abate the NWS, the TAND not to exceed a maximum amount effective to induce NES and the TAND to be determined by the human,

(c) about 16 to about 24 hours after application of the TNPD applied in step (b), removing the TNPD applied in step (b) and applying to the skin of the human at least one TNPD comprising a TAND effective to abate the NWS, the TAND not to exceed a maximum amount effective to induce NES and the TAND to be determined by the human,

(d) about 16 to about 24 hours after application of TNPD applied in step (c), removing the TNPD applied in step (c) and for a first continuous period of time, commencing upon the commencement of the treatment and extending about six weeks therefrom, and on an interval of about 24 hours, applying to the skin of the human at least one TNPD comprising a TAND effective to abate the NWS and removing the TNPD about 16 to about 24 hours after application thereof, the TAND not to exceed a maximum amount effective to induce NES and the TAND to be determined by the human,

(e) upon completion of the first continuous period of time, applying to the skin of the human at least one TNPD comprising a TAND effective to abate the NWS, the TAND not to exceed a maximum amount effective to induce NES and the TAND to be determined by the human,

(f) about 16 to about 24 hours after application of TNPD applied in step (e), removing the TNPD applied in step (e) and for a second continuous period of time, commencing upon commencement of step (e) and extending about two weeks therefrom, and on an interval of about 24 hours, applying to the skin of the human at least one TNPD comprising a TAND effective to abate the NWS and removing the TNPD about 16 to about 24 hours after application thereof, the TAND not to exceed a maximum amount effective to induce NES and the TAND to be determined by the human,

(g) upon completion of the second continuous period of time, applying to the skin of the human at least one TNPD comprising a TAND effective to abate the NWS, the TAND not to exceed a maximum amount effective to induce NES and the TAND to be determined by the human,

(h) about 16 to about 24 hours after application of TNPD applied in step (g), removing the TNPD applied in step (g) and for a third continuous period of time, commencing upon commencement of step (g) and extending about two weeks therefrom, and on an interval of about 24 hours, applying to the skin of the human at least one TNPD comprising a TAND effective to abate the NWS and removing the TNPD about 16 to about 24 hours after application thereof, the TAND not to exceed a maximum amount effective to induce NES and the TAND to be determined by the human,

(i) upon completion of step (h), the human abstaining from use of any TNPD or tobacco for a fourth continuous period of time, commencing upon completion of the third continuous period of time and extending at least seven days therefrom; and

(j) optionally, as determined by the human, for a fifth continuous period of time, commencing at least seven days after commencement of the fourth continuous period of time, but not more than a predetermined period of time, e.g. about 52 weeks from commencement of the treatment, and extending not less than about two weeks from commencement of the fifth continuous period of time, and on an interval of about 24 hours, applying to the skin of the human at least one TNPD containing a TAND effective to abate the NWS in the human and removing the TNPD about 16 to about 24 hours after application thereof, the TAND not to exceed a maximum amount effective to induce NES and the TAND to be determined by the human, until such time as the human abates tobacco use. In the present invention, the human adjusts the effective TAND based on the human's need to abate the NWS or to avoid or minimize the NES, and the necessity to exercise optional step (j) is determined by the human, based on criteria described herein. Should one determine that, in order to abate the NWS during treatment, one needs to revert back to a higher TAND, i.e. a rescue dosage, one may increase the TAND within the noted guidelines of treatment according to the severity of his/her particular NWS.

Claim 1 of 12 Claims

What is claimed is:

1. A patient-controlled method of treatment to abate tobacco use in humans, said method comprising:

(a) applying to the skin of a human at least one transdermal nicotine patch device comprising a total absorbable nicotine dose to be determined by the human which is effective to abate nicotine withdrawal symptoms, wherein the total absorbable nicotine dose does not exceed about 66 mg and does not induce nicotine excess symptoms;

(b) about 16 to about 24 hours after application of the transdermal nicotine patch device in Step (a), removing the transdermal nicotine patch device applied in Step (a) and applying to the skin of the human at least one transdermal nicotine patch device comprising a total absorbable nicotine dose to be determined by the human which is effective to abate nicotine withdrawal symptoms, wherein the total absorbable nicotine dose does not exceed about 66 mg and does not induce nicotine excess symptoms, provided that the total absorbable nicotine dose in Step (b) is greater than the total absorbable nicotine dose in Step (a);

(c) about 16 to about 24 hours after application of the transdermal nicotine patch device in Step (b), removing the transdermal nicotine patch device applied in Step (b) and applying to the skin of the human at least one transdermal nicotine patch device comprising a total absorbable nicotine dose to be determined by the human which is effective to abate nicotine withdrawal symptoms, wherein the total absorbable nicotine dose does not exceed about 66 mg and does not induce nicotine excess symptoms, provided that the total absorbable nicotine dose in Step (c) is greater than the total absorbable nicotine dose in Step (b);

(d) about 16 to about 24 hours after application of the transdermal nicotine patch device in Step (c), removing the transdermal nicotine patch device applied in Step (c) and for a first continuous period of time, beginning with the commencement of treatment and continuing for about six weeks therefrom, applying to the skin of the human at an interval of about 24 hours at least one transdermal nicotine patch device comprising a total absorbable nicotine dose to be determined by the human which is effective to abate nicotine withdrawal symptoms, wherein the total absorbable nicotine dose does not exceed about 66 mg and does not induce nicotine excess symptoms, and removing the transdermal nicotine patch device about 16 to about 24 hours after application thereof, provided that the total absorbable nicotine dose in Step (d) is less than or equal to the total absorbable nicotine dose in Step (c);

(e) after completion of the first continuous period of time, applying to the skin of the human at least one transdermal nicotine patch device comprising a total absorbable nicotine dose to be determined by the human which is effective to abate nicotine withdrawal symptoms, wherein the total absorbable nicotine dose does not exceed about 42 mg and does not induce nicotine excess symptoms;

(f) about 16 to about 24 hours after application of the transdermal nicotine patch device in Step (e), removing the transdermal nicotine patch device applied in Step (e) and for a second continuous period of time, beginning with the application in Step (e) and continuing for about two weeks therefrom, applying to the skin of the human at an interval of about 24 hours at least one transdermal nicotine patch device comprising a total absorbable nicotine dose to be determined by the human which is effective to abate nicotine withdrawal symptoms, wherein the total absorbable nicotine dose does not exceed about 42 mg and does not induce nicotine excess symptoms, and removing the transdermal nicotine patch device about 16 to about 24 hours after application thereof;

(g) after completion of the second continuous period of time, applying to the skin of the human at least one transdermal nicotine patch device comprising a total absorbable nicotine dose to be determined by the human which is effective to abate nicotine withdrawal symptoms, wherein the total absorbable nicotine dose does not exceed about 21 mg and does not induce nicotine excess symptoms;

(h) about 16 to about 24 hours after application of the transdermal nicotine patch device in Step (g), removing the transdermal nicotine patch device applied in Step (g) and for a third continuous period of time, beginning with the application in Step (g) and continuing for about two weeks therefrom, applying to the skin of the human at an interval of about 24 hours at least one transdermal nicotine patch device comprising a total absorbable nicotine dose to be determined by the human which is effective to abate nicotine withdrawal symptoms, wherein the total absorbable nicotine dose does not exceed about 21 mg and does not induce nicotine excess symptoms, and removing the transdermal nicotine patch device about 16 to about 24 hours after application thereof; and

(i) after completion of the third continuous period of time, the human abstains from using any transdermal nicotine patch device or tobacco for at least seven days, provided that in at least one of Steps (b)-(h), the total absorbable nicotine dose is greater than the total absorbable nicotine dose in the prior step.

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