Lucy Goods Inc. PMTA Accepted for Scientific Review and Key Data Accepted for Publication by The Society for Research on Nicotine and Tobacco (SRNT)

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LOS ANGELES, March 2, 2021 /PRNewswire/ -- Lucy Goods Inc., a provider of next generation nicotine products, announced today that data from their Premarket Tobacco Applications ("PMTA") was accepted for publication and included in presentations at the Society for Research on Nicotine and Tobacco ("SRNT") conference. The PMTA was submitted, accepted, and filed for scientific review by the FDA in 2020 and the expediency of the process is a testament to Lucy's work in the space.

Of the efficacy of the data, Dr. Willie McKinney PhD., DABT notes, "The science we provided the FDA shows that LUCY is a significantly better alternative for adult tobacco users. The health risks are negligible, and the population benefits can't be ignored. Furthermore, youth do not use LUCY and non-tobacco users are not interested. The Lucy Goods, Inc., PMTA's clearly demonstrate that LUCY meets all the criteria needed to receive market authorizations."

Catharine Dockery, Founding Partner at Vice Ventures, an investor in Lucy, says, "We're incredibly excited to see Lucy's harm reduction findings and their presentation at SRNT. One of the most attractive aspects of this investment and Lucy's founding team are their views on harm reduction and their goal of bringing tobacco's negative effects to zero. From the start, the company demonstrated real leadership in the space, coupling scientific and creative expertise with strong morals. We are proud and humbled to be along for the ride."

For the reader's convenience, summaries of the abstracts presented at SRNT are provided below:

Summary 1 (Lee)

Using a FDA-validated model and real-world data on smoking rates in the US population, we looked at what the public health impact of LUCY would have been over a period of 20 years if LUCY had been introduced in 1999. We find that, based on conservative estimates of the relative harm of LUCY compared to smoking, up to 120,000 lives could have been saved over that 20 year period. This is equal to the entire population of Ann Arbor, Michigan.

Summary 2 (Olson)

A collection of data from both actual LUCY users and people unfamiliar with the brand have confirmed several key points. First, that people who have not used LUCY understand that the product contains Nicotine and is thus still addictive. Second, LUCY may appeal to smokers who wish to quit as well as smokers who wish to continue using nicotine but are interested in decreasing or replacing their cigarette consumption. Finally, LUCY products do not appeal to people who have never smoked or people who have already quit smoking.

Summary 3 (Cyrus-Miller)

A toxicology analysis shows that LUCY contains extremely low levels (in many cases so low as to be unquantifiable) of known major carcinogens present in tobacco products. In cases where LUCY products contained any levels of potentially harmful chemicals, they were present at levels either lower or comparable to the leading name brand pharmaceutical nicotine gum.

Smoking remains the leading cause of preventable cause of death worldwide and in the US, and harm reduction (providing smokers with nicotine products that do not contain combusted tobacco) has proven to be a successful tobacco control strategy in other countries. Many tobacco consumers in the US are not motivated to switch to less harmful products because they are still unaware of the relative risks associated with consuming different nicotine products.

A key reason for this problem is the lack of publicity acknowledging that nicotine itself is not the main cause of harm in tobacco products. Products like LUCY can be critical tools for harm reduction efforts here in the US and we are grateful to our investors including RRE, Greycroft, and Vice Ventures who believe in a rational and data-driven approach to solving the greatest public health crisis of our time.

Abstracts Below:

WHAT MIGHT THE POPULATION HEALTH IMPACT HAVE BEEN HAD CHEW AND PARK ORAL TOBACCO PRODUCTS BEEN INTRODUCED INTO THE U.S. MARKET IN 1990?

Peter Lee1 , John Fry2 , Neil Sherwood3 , Samy Hamdouche4 , Willie McKinney5 . 1 P N Lee Statistics and Computing Ltd., Sutton, United Kingdom, 2 RoeLee Statistics Ltd., Sutton, United Kingdom, 3 Neil Sherwood Consulting, Nyon, Switzerland, 4 Lucy Goods, Inc., Los Angeles, CA, USA, 5 McKinney Regulatory Science Advisors, LLC., Henrico, VA, USA.

The FDA Center for Tobacco Products has encouraged the use of computational models to estimate potential changes (positive or negative) in public health following the introduction of a new tobacco product. LUCY CHEW AND PARK (LUCY) is a noncombustible oral gum-like product that contains 4 mg of tobacco-derived nicotine and is intended for, and marketed to, adult tobacco consumers for non-therapeutic use. LUCY therefore meets the definition of a tobacco product as set forth in the Federal Food, Drug, and Cosmetic Act. In preparation for a Premarket Tobacco Product Application, a Population Health Impact Model (Lee et al. 2017) was employed to examine what the impact on public health would have been over a 20 year period if LUCY had been introduced to the U.S. Market in 1990. With a conservative assumption that use of LUCY presents 5% of the risk of smoking cigarettes and under five different prevalence scenarios, the estimated reductions in death from four major smoking-related diseases combined (i.e. ischemic heart disease IHD, lung cancer, chronic obstructive pulmonary disease COPD, and stroke) ranged from 16,528 to 70,307 in males and 8,929 to 40,405 in females, with associated years of life saved ranging from 0.190 to 1.012 million in males and 0.096 to 0.482 in females. Modifying the risk for LUCY and sensitivity analyses did not markedly change the finding of a positive outcome on public health. These results suggest that the continued marketing of LUCY may contribute to a significant reduction in deaths from IHD, lung cancer COPD and stroke among cigarette smokers and lead to a saving of millions of life-years.

PERCEPTION AND INTENTION STUDIES - MAKING SENSE OF BEHAVIOR RESEARCH FOR NEW TOBACCO PRODUCTS

Cheryl K. Olson, M.P.H., Sc.D.1 , Neil Sherwood, Ph.D.2 , Samy Hamdouche, Ph.D.3 , Willie McKinney, Ph.D.4 . 1 Cheryl K. Olson Sc.D., LLC, San Carlos, CA, USA, 2 Neil Sherwood Consulting, Nyon, Vaud, Switzerland, 3 Lucy Goods, Inc., Los Angeles, CA, USA, 4 McKinney Regulatory Science Advisors, LLC, Henrico, VA, USA.

Perception, intention, and behavior studies are critical to help industry, regulators and the public understand how novel tobacco products may be used or misused, and their potential benefits or risks. Smaller companies or those new to regulatory requirements may struggle to understand what's needed and why. On October 27, the FDA issued draft guidance for industry on designing and conducting tobacco perception and intention studies. To illustrate how this guidance may be used, our presentation will share results of perception, intention and actual use behavior studies prepared for a premarket tobacco application for LUCY, a noncombustible oral gum-like product that contains 4 mg of tobacco-derived nicotine which is intended for, and marketed to, adult tobacco consumers for non-therapeutic use. The factors which influenced the research approach are explained and the results and planning of those studies are used to illuminate the practical difficulties and utility of behavioral research on novel tobacco products.

CHARACTERIZATION OF CHEW AND PARK ORAL TOBACCO DERIVED NICOTINE PRODUCTS

Helen Faye Cyrus-Miller. HFCyrus-Miller, LLC, Sandston, VA, USA.

LUCY is a noncombustible oral gum-like product that contains tobacco-derived nicotine and is intended for, and marketed to, adult tobacco consumers for non-therapeutic use. LUCY therefore meets the definition of a tobacco product as set forth in the FD&C Act and is regulated by the FDA Center for Tobacco Products. In preparation for a premarket tobacco application, we measured the FDA-established HPHCs for smokeless tobacco in LUCY and compared the results to other commercially available oral tobacco products, including an oral nicotine replacement therapy (NRT) product. Additionally, a toxicological risk assessment was conducted for all quantifiable non-nicotine HPHCs, with an estimated daily exposure assumption of 100% bioavailability from a maximum use of 24 pieces/day. Results show that LUCY contains nicotine levels similar to nicotine polacrilex (NRT) gum (4 mg) and similar HPHC levels. Measured HPHCs were either absent or significantly reduced when compared to other oral tobacco products. When compared to established regulatory values, estimated daily exposure to each of the quantifiable HPHCs was below established the lifetime regulatory limit for each analyte. In conclusion, levels of HPHC in LUCY suggests negligible toxicological concern for lifetime exposure and are similar to, or lower than, HPHC levels of smokeless tobacco products that are grandfathered or currently have FDA market authorization.

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