ARD-1600 - (Nicotine) Tobacco Smoking Cessation Therapy
to the National Center for Health
Statistics (“NCHS”), 21% of the U.S.
population age 18 and above currently smoke cigarettes. The World Health Organization
estimates that 650 million people worldwide are smokers, which results in a
health cost equivalent to $200 billion, $75 billion in the U.S.
alone. Further, the NCHS indicates that nicotine dependence is the most
common form of chemical dependence in this country. As a result, quitting
tobacco use is difficult and often requires multiple attempts, as users
often relapse because of withdrawal symptoms. Our goal is to develop an
inhaled nicotine product that would address effectively the acute craving
for cigarettes and, through gradual reduction of the peak nicotine levels,
wean-off the patients from cigarette smoking and from the nicotine
The initial laboratory work on this program was partly funded under grants
from the National Institute of Health. We have recently completed the first
human clinical trial delivering aqueous solutions of nicotine using the
palm-size AERx Essence® system. Our randomized, open-label, single-site
Phase 1 trial evaluated arterial plasma pharmacokinetics and subjective
acute cigarette craving when one of three nicotine doses was administered
to 18 adult male smokers. Blood levels of nicotine rose much more rapidly
following a single-breath inhalation compared to published data on other
approved nicotine delivery systems. Cravings for cigarettes were measured
on a scale from 0-10 before and after dosing for up to four hours. Prior to
dosing, mean craving scores were 5.5, 5.5 and 5.0, respectively, for the
three doses. At five minutes following inhalation of the nicotine solution
through the AERx Essence device, craving scores were reduced to 1.3, 1.7
and 1.3, respectively, and did not return to pre-dose baseline during the
four hours of monitoring. Nearly all subjects reported an acute reduction in
craving or an absence of craving immediately following dosing. No serious
adverse reactions were reported in the study.
believe these results provide the foundation for further research with the
AERx Essence device as a means toward smoking cessation. We are currently
seeking collaborations with government and non-government organizations to
further develop this product.
Cipolla D and
Gonda I. Inhaled Nicotine Replacement Therapy. Asian J Pharm
Gonda, I. et al.: “ Smoking Cessation Approach Via Deep
Lung Delivery of ‘Clean’ Nicotine”, PR Byron,
J Peart, JD Suman and PM Young (eds), Respiratory Drug Delivery
Europe 2009, book 1, pp.57-62
Cipolla D, et al. Development of an Inhaled AERx Essence Nicotine
Product for Smoking Cessation. In: Respiratory Drug Delivery
2008. 2008:365-369. Editors, Richard N. Dalby, Peter R. Byron,
Joanne Peart, Julie D. Suman, Stephen J. Farr. Published by
Davis Healthcare Int’l Publishing LLC, River Grove, IL.
Scottsdale, AZ, May 11-15, 2008.