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The Role of Opioid Abuse Deterrents in Today’s HealthcareSandeepkumar BalabbigariErnest Mario School of Pharmacy, Pharm.D. Candidate 2016April 20th, 2016
Objectives
▪ Describe the defining characteristics of opioid abuse and abuse deterrent products
▪ Discuss the changes in opioid abuse prevalance and medical costs after the introduction of Abuse-Deterrent OxyContin
▪ Review the actions taken by the FDA and the pharmaceutical industry in response to the opioid abuse epidemic
“The most important thing we can do is reduce demand for drugs, and the only way that we reduce demand is by providing treatment and thinking about this as a public health problem and not just a criminal issue.
- Barack ObamaMarch 29, 2016
BackgroundWhat is Opioid Abuse?
How Prevalent is Opioid Abuse? How Much Does Opioid Abuse Cost Society?
Differentiating Abuse
Abuse2
Use of an illegal drug or excessive use or misuse of a legal drug beyond its intended purpose or prescription
Dependence1,2
Physiological condition in which the body has adapted to a drug’s effects upon repeated exposure
Addiction1
Psychological condition in which there is a craving or an inability to control impulses in engaging in a specific activity
1) The National Alliance of Advocates for Buprenorphine Treatment. http://www.naabt.org/addiction_physical-dependence.cfm. Published March 12, 2016. Accessed April 6, 2016. 2) Saint Xavier University. http://www.sxu.edu/student-life/counseling/aodp/self/subabuse.asp. Accessed April 6, 2016.
Mechanisms of AbuseMethods of Manipulation1
▪ Crushing or grinding into a fine powder or small particles
▪ Dissolving in solvents such as alcohol
▪ Extracting through exposure to hot or cold temperatures
Routes of Abuse2
▪Oral▪Parenteral▪ Inhalation▪Smoking
1) Teva Pharmaceuticals USA, Inc. http://painmatters.com/healthcare-professionals/understanding-abuse-misuse.aspx. Published December 2015. Accessed April 6, 2016. 2) Teva Pharmaceuticals USA, Inc. http://painmatters.com/docs/BB157_WM.pdf Published April 2015. Accessed April 6, 2016.
Signs & SymptomsofOpioidAbuse
Constipation
Emotional Changes
Constricted Pupils
IV Track Marks
DeterioratingAppearance &
Hygiene
Acetaminophen Toxicity
Stolbach, A, et al. Acute opioid intoxication in adults. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA, 2016. Accessed April 6, 2016.
Prevalence
Free from Relatives
and Friends51%
Doctor's Precription
22%
Other27%
Source of Opioids1
4.3 million Americans engaged in non-medical use of prescription painkillers within the past month. 1.9 million meet criteria for prescription painkillers use disorder.1
1.4 million people used prescription painkillers non-medically for the first time in the past year. The average age of first-time abusers was 21.2 years.1
05000
1000015000200002500030000
Opioid Overdose Deaths2
0
5000
10000
15000
200002500030000
2008 20122014
1) Substance Abuse and Mental Health Services Administration. http://www.samhsa.gov/atod/opioids. Published February 23, 2016. Accessed April 8, 2016. 2) Centers for Disease Control and Prevention. http://www.cdc.gov/drugoverdose/epidemic/index.html. Published March 14, 2016. Accessed April 8, 2016.
Cost
$58.4 Billion
$26.2 Billion
$24.2 Billion
Estimated total societal costs of prescription opioid abuse in 2011
45% of total societal costs were associated with healthcare costs
92.4% of healthcare costs were due to excess medical and prescription costs
Kirson N, et al. American Academy of Pain Medicine. 2014
DeterrentsHow Do Prescription Painkillers Combat Opioid Abuse?
No opioid formulation can prevent the most common method of abuse: ingestion of a large number of intact dosage forms
Opioid products can be formulated with abuse-
deterrents to make their intentional nontherapeutic
use more difficult, less attractive, or less rewarding
The Medical Letter. http://secure.medicalletter.org/w1476a. Published August 31, 2015. Accessed April 6, 2016.
Currently ApprovedAbuse Deterrent Formulations (ADF)
OxyContin®1
(Oxycodone HCl)▪ More resistant to
breaking or crushing▪ Forms viscous gel when
dissolved ▪ 17% and 66% reductions
in oral and non-oral abuse, respectively
Embeda® 1
(Morphine sulfate and Naltrexone HCl)▪ Formulated as capsules
of ER morphine pellets that contain a sequestered core of naltrexone
▪ Naltrexone is only released if formulation is manipulated
Hysingla® ER1,2
(Hydrocodone bitartrate)▪ Utilizes RESISTEC
technology▪ Increased tablet
hardness ▪ Forms viscous gel when
dissolved
Significantly lower “Drug Liking”, “Drug High”, and “Take Drug Again” compared to previous formulations
1) The Medical Letter. http://secure.medicalletter.org/w1476a. Published August 31, 2015. Accessed April 6, 2016. 2) Weinstein SM. Therapeutics and Clinical Risk Management. 2009
New OxyContinFormulation
Potential Abuse-Deterrent TechnologiesDETERx▪ Drug molecules are
formulated into a fatty-acid-ionic complex
▪ Bioequivalence and time-release properties remain unchanged even after manipulation
Bio-Activated Molecular Delivery (Bio-MD)▪ Drug molecules are bound to
an amino-acid mask▪ Drug remains inactive until
amino-acid mask is cleaved▪ Systemic exposure is not
increased by chewing, crushing, or dissolvingthe formulations
Moorman-Li R., et al. Pharmacy and Therapeutics, 2012
ImpactWhat Effect Have Abuse-Deterrent Formulations
Had On Opioid Abuse Prevalance?
Changes in Opioid Abuse Prevalence Associated with ADF OxyContin
232,875 adults assessed for substance abuse problems using the computerized Addiction Severity Index-Multimedia Version (ASI-MV)
Designed to assess trends of past 30-day abuse and changes in abuse patterns after ADF OxyContin was introduced
ADF = Abuse-Deterrent Formulation
Prevalence of abuse was measured by the proportion of subjects with past 30-day abuse
Cassidy T, et al. American Academy of Pain Medicine. 2014
Changes in Opioid Abuse Prevalence Associated with ADF OxyContin
Abuse BeforeADF OxyContin
Abuse AfterADF OxyContin
Relative Percent Change
Statistically Significant?
All Prescription
Opioids 16.94% 18.36% +8.3% YesImmediate
Release (IR) Opioids 9.70% 10.72% +2.5% No
Extended Release (ER)
Opioids 12.57% 12.88% +10.5% YesData presented as percent of all subjects assessedADF = Abuse-Deterrent Formulation
Cassidy T, et al. American Academy of Pain Medicine. 2014
Changes in Opioid Abuse Prevalence Associated with ADF OxyContin
Abuse BeforeADF OxyContin
Abuse AfterADF OxyContin
Relative Percent Change
Statistically Significant?
Oxycodone ER 6.49 5.08 −21.7% YesOxymorphone ER 0.32 0.94 +190.9% Yes
Morphine ER 1.13 1.10 -2.65% NoBuprenorphine 2.42 4.47 +84.7% Yes
Heroin 5.55 4.94 -10.99% Yes
Cassidy T, et al. American Academy of Pain Medicine. 2014
Data presented as percent of all subjects assessedADF = Abuse-Deterrent Formulation
The introduction of ADF OxyContin hadlittle impact on the
overall prevalence of prescription opioid abuse.
ADF = Abuse-Deterrent Formulation
Changes in Opioid Abuse Prevalence Associated with ADF OxyContin
Cassidy T, et al. American Academy of Pain Medicine. 2014
ImpactWhat Effect Have Abuse-Deterrent Formulations
Had On Healthcare Costs?
Medical Cost Savings Associated with ADF OxyContin
Measure changes in number of
opioid abuse diagnoses
Estimate the excess medical
costs associated with
diagnosed opioid abuse
Determine the cost savings of ADF OxyContin
ADF = Abuse-Deterrent FormulationRossiter L, et al. Journal of Medical Economics. 2014
Reduction of 48,737 opioid
abusers
$8,814 is the average annual excess medical
costs for an opioid abuser
$430 million annual medical
cost savings
Medical Cost Savings Associated with ADF OxyContin
ADF = Abuse-Deterrent FormulationRossiter L, et al. Journal of Medical Economics. 2014
$430,000,000Annual medical cost savings associated with the
introduction of ADF OxyContin
ADF = Abuse-Deterrent FormulationRossiter L, et al. Journal of Medical Economics. 2014
$286 $573Potential range of annual medical cost savings (millions)
ResponseHow Has the Opioid Abuse Epidemic
Affected Stakeholders?
FDAResponse
Risk Evaluation and Mitigation Strategy (REMS) Program1
Requires companies that produce ER/LA opioid analgesics to provide training and education for both prescribers and patients
ER/LA = Extended-release/Long-acting
Abuse-Deterrent Opioids - Evaluation and Labeling Guidance for Industry2
Explains the pre-market studies needed for the approval of abuse-deterrent claims inproduct labeling
Opioids Action Plan3
Comprehensive list of initiatives to be taken by the FDA with the intent of reducing opioid abuse and overdose deaths in the United States
1) U.S. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm. Published January 27, 2016. Accessed April 11, 2016. 2) U.S. Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf. Published April 2015. Accessed April 11, 2016. 3) U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.html. Published February 5, 2016. Accessed April 11, 2016.
Industry Response
Teva Pharmaceuticals USA, Inc. http://painmatters.com/people-affected-by-pain/community-resources-people-affected-chronic-pain.aspx. Published December 2015. Accessed April 13, 2016.
Conclusion
Abuse deterrent formulations may
reduce the abuse of a specific drug but are
not the “magic bullet” to solving the opioid
abuse epidemic.
The government, pharmaceutical industry,
healthcare providers, and patients all have a role to play in reducing
opioid abuse.
Thank you!BackgroundQuestions?