Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1998-09-29
2001-05-01
Levy, Neil S. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S444000, C424S446000, C424S449000, C514S343000, C514S813000
Reexamination Certificate
active
06224897
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to methods of treatment to abate the use of tobacco by humans.
BACKGROUND OF THE INVENTION
Transdermal patches containing nicotine have been tested, approved and marketed as nicotine replacement products. Reported methods for using such transdermal patches typically utilize fixed, non-aggressive dosage regimens, some of which include tapering of the level of nicotine in the transdermal patches over the course of the treatment period. For example, the labeling of some products impose fixed tapering dosing schemes which utilize transdermal patches containing about 21 milligrams (mg) of total absorbable nicotine for 6 weeks, transdermal patches containing about 14 mg of total absorbable nicotine for 2 weeks, and transdermal patches containing about 7 mg of total absorbable nicotine for 2 weeks. Other reported methods utilize a fixed dosing scheme, i.e. there is no tapering of the amount of absorbable nicotine present in the transdermal patch. For instance, it has been reported to use transdermal patches containing about 15 mg of absorbable nicotine for 6 weeks.
Two published clinical studies compare quit rates for 22 mg and 44 mg patches. Neither study demonstrated a statistically significant difference in long term quit rates, though end of treatment success rates were significantly higher in those receiving the 44 mg dose. However, a sub-analysis suggested that in patients receiving minimal smoking cessation guidance, the 44 mg dose produced greater abstinence than did the 22 mg dose (68% vs. 45%, p<0.01) at the end of 4 weeks of treatment. Patients receiving individual or group counseling did not demonstrate this significant effect. Other studies suggest that smokers who use standard-dose nicotine patches as directed, who have few adverse effects, and who relapse because of persistent nicotine withdrawal symptoms or craving should be considered for dosages higher than 21 mg per day of standard patch therapy.
Two publications have reported higher quit rates when nicotine patches, used according to conventional teachings, were supplemented with nicotine gum.
There is consistent evidence from existing clinical trials that currently reported dosing schemes utilizing transdermal nicotine patches alone provides less than adequate nicotine replacement in most smokers. While it has been shown that at one year after initiation of reported nicotine treatment methods, successful quit rates are twice those of placebo, nevertheless, even with treatment by a general practitioner, less than 1 out of 4 attempts to cease using tobacco are successful in the first 2-3 months of a cessation attempt when reported methods of treatment are used.
Irregardless of which reported method is used, at the end of the conventional, pre-determined and fixed treatment period, there is no provision or consideration for those “treated” patients who either have exhausted the conventional treatment methods, yet still have the need to use tobacco products, or have failed to complete the conventional treatment methods due to their unabated need to use tobacco products. Accordingly, improved methods of treatment to eliminate or substantially reduce the need in humans to use tobacco are desirable.
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.
Levy Neil S.
Novartis Consumer Health S.A.
Thallemer John D.
LandOfFree
Methods to abate the use of tobacco by humans does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods to abate the use of tobacco by humans, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods to abate the use of tobacco by humans will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2436492