Current trends indicate that approximately 500 million of the
world's existing cigarette smokers will prematurely die of causes
that could be prevented by treatment of their addiction to tobacco
delivered nicotine. Initial pharmacologically based treatment
offerings and approaches have proven the concept that increasing
the accessibility and diversity of treatment modalities helps
more people quit smoking. These treatments have also shown,
however, that the vast majority of smokers continues to find
treatment less attractive and less accessible than cigarettes
whose appeal is constantly stimulated by new formulations, marketing
strategies, and implied claims of reduced risk. There appears
to be considerable untapped potential public health benefit,
as well as commercial opportunity, for medication developers
to reach an increasing fraction of smokers who find current
treatments unacceptable, inaccessible, or ineffective. The global
opportunities to serve public health via medication development
are growing even more rapidly as country after country recognizes
the impending economic and health care problems posed by tobacco
dependence and are opening their doors to treatment. Three areas
of medications development offer particular promise: new forms
of nicotine delivery, non-nicotine based medications, and new
indications to reach those who are unable or unwilling to completely
quit. This article discusses the biobehavioral rationale for
medication development, the opportunities, and some of the prominent
technical and regulatory challenges.