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SmartStop™
A Smart Personalized Alternative for
Nicotine Replacement Therapy
2014 AAPS Annual Meeting and Exposition
Programmable Transdermal Drug Device Technologies
Sunrise Session
San Diego, California
November 4th, 2014
Vishwas Rai, PhD
Product Development Manager
Chrono Therapeutics, Inc.
Outline
-Smokers Craving Patterns
-Existence of Chrono-biology
-Unmet Market Needs and Room for improvement
-Nicotine Chemistry
-SmartStop™ IntroductionApproachTechnology Working Mechanism Behavioral Support Tool
-Summary
-Acknowledgement
Chrono-biology (Humans)
Circadian Rhythms in Craving (to smoke)
Smokers have clear, consistent and predictable daily peak cravings times
Scientifically-established value of refractory periods (“peaks” with “troughs”)
Current NRT fails to provide a sufficient nicotine dose nor timed to craving cycle
Addressing a Major Unmet Medical Need
• Smoking kills >440k Americans each year and 5M globally;
responsible for approximately one in five deaths in the US(1)
• 70% of the 45M US smokers want to quit; 23M try to quit
each year(2)
• The average smoker attempts to quit 8-10 times(3)
• NRT’s account for 60-75% of all smoking cessation therapies sold worldwide(2) but efficacy <10%(4)
1. American Lung Association, Trends in Tobacco Use, Epidemiology and Statistic Unit, July 2011
2. Center for Disease Control and Prevention, Quitting Smoking Among Adults-United States 2001-2010, Morbidity and Mortality Weekly Report 2011
3. American Cancer Society
4. Bullen et al., “Electronic Cigarettes for Smoking Cessation: A Randomised Controlled Trial,” The Lancet, Nov. 2013; Shiffman and Rolf, “Real-world Efficacy of
Prescription and Over-the-Counter Nicotine Replacement Therapy,” Addiction, May 2002; Moore et al., “Effectiveness and Safety of NRT Assisted Reduction to
Stop Smoking: Systematic Review and Meta-Analysis,” BMJ, 2009
Opportunity to Improve NRT Efficacy
1. Efficacy based on findings from Renee Bittoun study titled, “A Combination Nicotine Replacement Therapy (NRT) Algorithm for Hard-to-Treat Smokers,” 2006;
implied 6 month abstinence calculated using 20% decline in abstinence from 3 mth levels based on study titled, “Transdermal nicotine therapy and primary care.
Importance of counseling, demographic, and participant selection factors on 1-year quit rates,” The Nebraska Primary Practice Smoking Cessation Trial Group,”1998
2. Walsh R., “Over the Counter Nicotine Replacement Therapy: A Methodological Review of the Evidence Supporting Its Effectiveness,” Drug and Alcohol Review, 2008
3. Piper M.E. et al., “A Randomized Placebo-controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies,” Arch Gen Psychiatry, 2009
0% 10% 20% 30% 40% 50% 60%
Optimally Dosed NRT (1)
Chantix (2 mg/day)
Patch (> 14 weeks) + Gum / Spray
Nicotine Inhaler
Patch + Inhaler
Nicotine Patch ( > 14 weeks)
Nicotine Gum
• Combination therapy (i.e. patch + gum) is one of the most preferred method and it is a “Do-it-yourself” therapy.
• “Do-it-yourself” combo NRT therapy too burdensome for long-term compliance(2)(3)
• Optimally dosed NRT can achieve ~50% efficacy(1)
Nicotine Chemistry and Permeation
SmartStop™
The world’s first programmable and wearable
smoking cessation therapy.
• Synchronized with
Cravings to Prevent
Relapse
• Automatic and
Reliable
• Personalized and
Responsive
Smart drug delivery
Real-time Compliance
Real-time Behavioral
Support
Three-pronged Solution to Optimize Drug Efficacy
The Technology
Drug-Metering Membrane
SKIN
Drug Reservoir
Solvent Removal Element
Personalized Craving Monitoring
Tailored Dosing
Digital Behavioral
Support
Bluetooth enabled
How it Works
Leverages algorithms
to preempt powerful
nicotine cravings,
delivering medication
just when it's needed
most.
Provides individualized
and intelligent coaching
to manage the
personal, emotional
and behavioral sides of
quitting.
Matches medication
and behavioral support
to smokers' patterns
and adapts the
program as needs
change.
Behavioral Support Tools
• Skills building and evidence-based
coping exercises
• Proactive reminders / encouragement
• Family / other support networks
• Progress rewards
• Progressive tailoring based on data
inputs
Summary
• There has been little advancement in smoking
therapy technology from last 2-3 decades and
efficacy of NRT is low (~10%).
• NRT + Behavioral Support can double efficacy
• SmartStop’s personalized system times medication
delivery to smokers’ craving patterns and provides
proactive real-time digital support, leading to a true
breakthrough in cessation therapy.
Acknowledgements
• Alan Levy
• Patrick Ruane
• Jenny Hapgood
• Evans Roth
• Steve Giannos