Reducing Prescription Drug Abuse with Abuse-Resistant and Use-Reducing Technologies: REMOXY® &...
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Reducing Prescription Drug Abuse with Abuse-Resistant and Use-Reducing Technologies: REMOXY® & POSIDUR™ CONFIDENTIAL1 Jim Brown, D.V.M. President and CEO,
Reducing Prescription Drug Abuse with Abuse-Resistant and
Use-Reducing Technologies: REMOXY & POSIDUR CONFIDENTIAL1 Jim
Brown, D.V.M. President and CEO, DURECT Corporation
Slide 2
Prescription Opioid Abuse and DURECT Development Candidate:
REMOXY Development Candidate: POSIDUR Summary & Next Steps
CONFIDENTIAL2
Slide 3
3 1. Institute of Medicine, 2011 survey of U.S. adults
reporting that they had pain in the past three months 2. Archives
of Internal Medicine, 2011: Office of National Drug Control Policy
100 Million Americans Suffer from Chronic Pain Chronic pain affects
100 million Americans 1 4 million Americans per year are prescribed
a long-acting opioid 2 KEY OBSERVATIONS
Slide 4
CONFIDENTIAL4 1. Drug Abuse Warning Network (DAWN) SOURCE:
Atluri et al. Pain Physician 2014; 17:E119-E128 Opioid Misuse
Thousands of DAWN 1 visits Opioid Misuse Thousands of DAWN 1 visits
Opioid Use Billions of grams Opioid Use Billions of grams Opioid
Misuse 3x Opioid Use and Growing Opioid Use increased by 1,349% in
15 years Concurrently, Opioid Misuse has increased by 4,680% KEY
OBSERVATIONS 1996 2004 2011
Slide 5
CONFIDENTIAL5 Opioid Misuse Thousands of DAWN 1 visits Opioid
Misuse Thousands of DAWN 1 visits Opioid Use Billions of grams
Opioid Use Billions of grams Opioid Misuse 3x Opioid Use and
Growing Opioid Misuse grew at 3X the rate of Opioid Use KEY
OBSERVATIONS 1996 2004 2011 1. Drug Abuse Warning Network (DAWN)
SOURCE: Atluri et al. Pain Physician 2014; 17:E119-E128
Slide 6
SOURCE: Centers for Disease Control and Prevention.
Unintentional Drug Poisoning in the United States (July 2010).
CONFIDENTIAL6 Opioid Deaths 3-6x More Common than Cocaine Deaths or
Heroin Deaths Opioid Overdose Deaths are: 3x Cocaine Deaths 6x
Heroin Deaths KEY OBSERVATIONS OPIOIDS COCAINE HEROIN
Slide 7
Leading Causes of Injury Death Thousands of Deaths
CONFIDENTIAL7 SOURCE: National Center for Health Statistics. Data
Brief: Drug Poisoning Deaths in the United States, 1980-2008.
December 2011. No.81. Updated with 2009 and 2010. Drug Poisoning
surpassed motor vehicle traffic-related injuries as the leading
cause for injury death in U.S. KEY OBSERVATIONS Motor Vehicle
Traffic Drug Poisoning: Leading Cause For Injury Death
Slide 8
CONFIDENTIAL8 REMOXY POSIDUR Abuse-Resistant Formulations Our
focus is on developing technologies to reduce prescription drug
abuse Reduce Opioid Use and Exposure DURECTs Commitment to the
Patient
Slide 9
Prescription Opioid Abuse and DURECT Development Candidate:
REMOXY Development Candidate: POSIDUR Summary & Next Steps
CONFIDENTIAL9
Slide 10
10 Automobiles: Setting The Standard for Safety Photo:
http://eblog.mercedes-benz-passion.com/2011/03/diesel-engines-in-mercedes-benz-passenger-cars/
Slide 11
CONFIDENTIAL11 Automobiles: Setting The Standard for Safety
Photo: Courtesy of the Boston Public Library, Leslie Jones
Collection.
Slide 12
CONFIDENTIAL12 Automobiles: Setting The Standard for Safety
Photo:: car.mitula.us
Slide 13
CONFIDENTIAL13 Automobiles: Setting The Standard for
Safety
Slide 14
AUTOMOBILEAUTOMOBILE Seatbelt: Lap Seatbelt: Shoulder Front
Airbags Side Airbags Crumple Zones CONFIDENTIAL14 REMOXY Sets
Standard for Safety Automobile Safety Measures vs. Common Methods
of Drug Abuse REMOXYREMOXY Snort Inject Chew Smoke Combine with
Alcohol
Slide 15
CONFIDENTIAL15 OXYCONTIN Photo: Copyright 2011 The New York
Times Company
Slide 16
CONFIDENTIAL16 REMOXY Sets Standard for Safety Photo: Copyright
2011 The New York Times Company OXYCONTIN OXYCONTIN TR
Slide 17
CONFIDENTIAL17 REMOXY Sets Standard for Safety Photo: Copyright
2011 The New York Times Company OXYCONTIN OXYCONTIN TR REMOXYREMOXY
Snort Inject Chew Smoke Combine with Alcohol REMOXY
Slide 18
CONFIDENTIAL18 Clinical Data Demonstrate that REMOXY Reduces
Abuse-Potential Compared to Oxycodone Drug Liking was significantly
lower* for REMOXY Time to Peak Drug Liking was significantly
delayed* for REMOXY No patient could chew REMOXY for more than 1.5
minutes due to taste and texture * p
*p=0.0664 ; derived using CMH Chi-Square test adjusted by study
sites **p=0.0309 ; derived using CMH Chi-Square test adjusted by
study sites POSIDUR May Reduce Opioid Prescriptions After Surgery
Hernia Surgery Percent Patients Not Taking Opioids Shoulder Surgery
Percent Patients Not Taking Opioids >20% MORE patients did not
require a single opioid +24% p = 0.0309*
Slide 27
CONFIDENTIAL27 Hernia Surgery Shoulder Surgery > 20% more
patients didnt require a single opioid p = 0.0664* p = 0.0309*
Original from Corporate Slides POSIDUR : Proportion of Patients NOT
Taking ANY Supplemental Opioid 0-72 Hrs
Slide 28
CONFIDENTIAL28 Over 20% MORE PATIENTS DID NOT REQUIRE A SINGLE
OPIOID POST-SURGERY
Slide 29
CONFIDENTIAL29 800,000 Surgeries 800,000 Patients 160,000
Avoided Prescriptions Prevalence of Hernia Surgeries per year in
U.S. 100% of patients exposed to opioid prescription 20% of
Prescriptions Avoided 5-10% of population genetically susceptible
to opioid abuse 1 SOURCE: Hoffman, Matthew. Prescription Drug
Abuse: Who Gets Addicted and Why?. www.webmd.com. Accessed May 1,
2014.www.webmd.com Potential Impact 8,000-16,000 8,000-16,000 FEWER
ABUSERS PER YEAR 8,000-16,000 8,000-16,000 FEWER ABUSERS PER YEAR
POSIDUR Potentially Prevents Thousands of Abusers Per Year
Slide 30
CONFIDENTIAL30 70M Surgeries 35M Patients 7 Million Avoided
Prescriptions SOURCE: Hoffman, Matthew. Prescription Drug Abuse:
Who Gets Addicted and Why?. www.webmd.com. Accessed May 1,
2014.www.webmd.com Prevalence of Surgeries per year in U.S. 20% of
Prescriptions Avoided 5-10% of population genetically susceptible
to opioid abuse 1 POSIDUR Potentially Prevents Thousands of Abusers
Per Year Potential Impact 50% of patients exposed to opioid
prescription 350,000-700,000 FEWER ABUSERS PER YEAR
Slide 31
CONFIDENTIAL31 FDA is Committed to Reducing the Abuse of
Opioids Let me say, in no uncertain terms: the prevention of
prescription opioid abuse is of the highest priority for the FDA.
Nothing can erase the tragedy so many people have had to face as a
result of abuse, addiction, or misuse of opioids. But we can make
meaningful progress to reduce and prevent our nations prescription
drug crisis. FDA is committed to reducing abuse of opioids and
ensuring appropriate access to pain medicines for patients in need.
Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug
Administration, stated on April 29, 2014:
Slide 32
CONFIDENTIAL32 FDA has determined that they cannot approve the
NDA in its present form, stating the NDA does not contain
sufficient information to demonstrate that POSIDUR is safe when
used in the manner described in the proposed label, and the FDA has
indicated that additional clinical safety studies need to be
conducted. POSIDUR Complete Response Letter POSIDUR Complete
Response Letter Food and Drug Administration February 12, 2014
Slide 33
Prescription Opioid Abuse and DURECT Development Candidate:
REMOXY Development Candidate: POSIDUR Summary & Next Steps
CONFIDENTIAL33
Slide 34
REMOXY and POSIDUR have both been submitted to the FDA for
approval, and both approvals have been delayed. DURECT is committed
to reducing pain and opioid abuse. DURECT continues to engage with
FDA to bring these two critical products to market. How you can
help CONFIDENTIAL34 Summary and Next Steps
Slide 35
Opioid use and abuse is a fast-growing and critical concern in
the U.S. Medical providers can impact these trends by turning to
smarter drug technology FDA claims that introducing drug
formulations to reduce prescription drug abuse is their top
priority Novel medications in development with abuse-resistant
technology, such as REMOXY and POSIDUR, are direly needed to
address the prescription drug abuse epidemic in the United States.
CONFIDENTIAL35 Summary and Next Steps Alternative 1
Slide 36
CONFIDENTIAL36 REMOXY has been delayed since 2008 by 2 Complete
Response Letters: Due to primarily manufacturing concerns Pfizer
expects to resubmit mid-2015 POSIDUR Complete Response Letter in
February 2014 FDA requesting additional safety data surrounding
surgical side-effects DURECT continues to engage with FDA senior
management to bring these products to market, so patients realize
their clear benefits REMOXY and POSIDUR Approval Delayed
Alternative 2