The proposed Proof of Concept Study seeks Phase I STTR funding to support a novel nicotine replacement therapy (NRT) pilot pharmacokinetic (PK) trail in healthy smokers. Very little by way of product development has occurred in the NRT field despite scientists'and clinicians'pleas for improved NRTs, specifically for a faster-acting NRT that resembles nicotine pharmacokinetics as produced by cigarette smoking 4-6. Preliminary PK data on this novel NRT suggests that the PK resembles that obtained from smoking a cigarette. The pilot PK study is designed as an open-label, randomized, 2-way crossover study comparing the novel NRT to the Over- the-Counter lozenge. Differences in product performance will also be evaluated for craving satisfaction and product preference criteria. Formal product stability data will also be obtained in the planned commercial container-closure-system. The collaboration between Friends Research Institute (FRI) [non-profit research institute] and Pharmaceutical Productions Inc. (PPI) [for-profit small business] represents a partnership that draws on complementary strengths and expertise of the respective organizations. PPI was formed to promote innovation in drug delivery and to assist pharmaceutical companies in obtaining market approval of their therapeutic products. PPI is the patent holder for this novel NRT. FRI provides an ideal institutional partner for conducting rigorous scientific research, with well-developed grants and research administration, an Institutional Review Board, and robust quality assurance systems. In this application, FRI scientists and physicians will perform the pilot PK study at the FRI clinic in Torrance, California. Dr. Neal Benowitz has kindly agreed to conduct the bioanalytical work at his UCSF lab. Funding for this project will advance three goals. First, funding will be fundamental to further development of this novel NRT by confirming the PK resembles that obtained from smoking cigarettes, that it reduces cravings and has desirable product performance attributes. Second, findings from the proposed study will provide pharmacokinetic data, craving information, product performance criteria, and stability data that my company needs to interest a corporate partner for its commercialization. Third, results of the proposed study will provide the foundation for a Phase II research program that will focus on the regulatory requirements for obtaining market approval. This novel NRT will provide for a real unmet clinical need as a safe, convenient, inexpensive smoking cessation therapy agent that satisfies a smoker's nicotine cravings, which current smoking cessation therapies fail to do. As such, it has potential to be a breakthrough product in smoking cessation therapy. Such a product would be a major benefit to public health by reducing tobacco consumption and the huge costs associated with treatment of smoking-related diseases. Tobacco use is the most preventable cause of disease, disability, and death. According to the World Health Organization (WHO), tobacco use results in about 5 million deaths annually - or, equivalently, every 61/2 seconds a current or former smoker dies from tobacco-smoking-related disease 9. If the current trend continues, that number will reach 8 million by 2030, with 80% of these premature deaths occurring in low- and middle-income countries 9. Even if the novel NRT does not turn out to be a breakthrough product as anticipated, the clinician will have one more effective arrow in the quiver for the treatment of smoking cessation, so much the better for human health.
This pilot pharmacokinetic (PK) is a Proof of Concept Study designed to substantiate that the PK from this novel nicotine replacement therapy (NRT) resembles that obtained from cigarette smoking;something that scientists'and clinicians'believe will be a major improvement in smoking cessation therapy. Further, an initial assessment of the product's performance will be determined by comparing this novel NRT to the lozenge, the most recently approved NRT. In addition to comparative PK, the two products will be compared with respect to nicotine craving satisfaction and product preference characteristics. This novel NRT promises to provide the smoker with a real unmet clinical need for a safe, convenient, inexpensive smoking cessation therapy that satisfies their nicotine cravings.