PBA Health PPOK OPHA - · PDF file1 PBA Health ° PPOK ° OPHA Opioids with Abuse‐Deterrent Properties and Claims (OADP) By Kelley Waara‐

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PBA Health ° PPOK ° OPHA

Opioids with Abuse‐Deterrent Properties and Claims (OADP)

By

Kelley Waara‐Wolleat, PharmD, MBA

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Synergy Conference PBA HEALTH • PPOK • OPHA


Opioids with Abuse Deterrent Properties andClaims (OADP)

KelleyWaara Wolleat, PharmD, MBAAssociate Director, Medical Science Liaison, Purdue Pharma, L.P.

0401 0000 17 305 L01 P/T

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CPE CODE:Opioids with Abuse Deterrent Properties and Claims (OADP)


Faculty Disclosures

KelleyWaara Wolleat

Kelley Waara Wolleat has the following disclosures to report:• Employment by Purdue Pharma, L.P.

Drug Store News has completed independent peer review processes toresolve any potential conflicts of interest in relation to this activity.

This program shall exhibit fair content balance, providing the audience with information of differentperspectives from which an informed professional opinion can be developed.

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Learning Objectives Pharmacists

• Describe the importance of medications with Opioids with AbuseDeterrent Properties (OADP) .

• Review the FDA guidance provided for developers of Opioids withAbuse Deterrent Properties (OADP) medications.

• Identify resources to find Abuse Deterrent Properties and Claims• List current and future technologies studied for Opioids with AbuseDeterrent Properties (OADP) medications.


Learning Objectives Technicians

• Describe the importance of medications with Opioids with AbuseDeterrent Properties (OADP).

• Review the FDA guidance provided for developers of Opioids withAbuse Deterrent Properties (OADP) medications.

• Identify resources to find Abuse Deterrent Properties and Claims• List current and future technologies studied for Opioids with AbuseDeterrent Properties (OADP) medications.

12PBA Health Kansas City, MO 06/25/2017

MR 00139

Opioids withAbuse Deterrent Properties

and Claims (OADP)

Kelley Waara Wolleat, PharmD, MBAAssociate Director, Medical Science Liaison

Purdue Pharma L.P.

Overview of Emerging Technologies

All rights reserved. © 2015, Purdue Pharma L.P.

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Synopsis

• This presentation will provide information about:

– The reasons OADP are important innovations

– The FDA’s direction to those developing OADP

– Where to find Abuse Deterrent Properties and Claims

– Some technologies employed or under study for OADP

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The Problems

• Concurrent public health problems in the UnitedStates:

– Endemic nonmedical use/misuse ofprescription pain medicines

– Epidemic fatal overdoses involving opioidanalgesics

– Endemic chronic pain

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National Survey on Drug Use & HealthNSDUH

• Authorized by federal statute, began in 1971• Data used to implement and measure drug policy• Annual, face to face, computer assisted interview• Approximately 70,000 persons, age 12 and older

• 2002 2014: Nonmedical use determined by:“Have you ever, even once, used any prescriptionpain reliever that was not prescribed for you, orthat you took just for the experience or feeling itcaused?”

National Survey on Drug Use and Health, Frequently Asked Questions https://nsduhweb.rti.org/respweb/faq.html Accessed 10 October 2016http://www.samhsa.gov/data/sites/default/files/NSDUH MethodSummDefs2014/NSDUH MethodSummDefs2014.htm#secc Pain Reliever UseAccessed 10/11/2016

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Nonmedical Use (NMU)Opioid Analgesic Incidence Trends

Persons 12 y/o Initiating NMU in Past Year (%)

http://www.samhsa.gov/data/sites/default/files/NSDUH DetTabs2014/NSDUH DetTabs2014.htm#tab7 44aNational Survey on Drug Use and Health (NSDUH) Tables 7.44A&B

0.0

0.2

0.4

0.6

0.8

1.0

1.2

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

1.425 MM

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Nonmedical Use (NMU)Opioid Analgesic Prevalence Trends

Persons 12 y/o with Current (Past Month) NMU, by Year (%)

0.0

0.5

1.0

1.5

2.0

2.5

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

http://www.samhsa.gov/data/sites/default/files/NSDUH DetTabs2014/NSDUH DetTabs2014.pdf; Tables 7.3A&B

4.325 MM

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Use and MisusePrescription Pain Relievers (PPR)

• NSDUH changed some questions in 2015• Asked about any use as well asmisuse• Misuse defined only by behaviors:

– Use in any way a doctor did not direct, including use without aprescription of one’s own, use in greater amounts, more often,or longer than directed, or use in any other way not directed bya doctor.

• Change creates a break in trend for Rx drugs, but notheroin, cocaine, marijuana.

• Past Year Initiation of PPR Misuse = 2,126,000 (0.8%)• Past Year Prevalence of PPR Misuse = 12,462,000 (4.7%)• Past Month PPR Misuse = 3,775,000 (1.4%)

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A Hughes, et al. Prescription Drug Use and Misuse in the United States: Results from the 2015 National Survey on Drug Use and Health. SAMHSASeptember 2016 http://www.samhsa.gov/data/sites/default/files/NSDUH FFR2 2015/NSDUH FFR2 2015.htm Accessed 10/11/2016CBHSQ (2016). 2015 National Survey on Drug Use and Health: Detailed Tables.SAMHSA, Rockville, MD. Tables 7.34A&B, 7.2 A&B, 7.3A&B

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Main Reason for Last Episode ofMisuse of Prescription Pain Relievers

(2015)

* Total = 100.1%: If respondent gave more than one reason, they were prompted to indicate the most important reason.

http://www.samhsa.gov/data/sites/default/files/NSDUH DetTabs 2015/NSDUH DetTabs 2015/NSDUH DetTabs 2015.pdf Table 6.65BAccessed 10/11/2016

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Past Year Misuse = 12,462,00097% of Respondents Provided a Reason*

Relieve PhysicalPain62.6%

12.1%

10.8%

4.4%

3.3%

2.5%2.3% 1.2% 0.9% Relieve Physical Pain, 62.6%

Feel Good Or Get High, 12.1%

Relax or Relieve Tension, 10.8%

Help With Sleep, 4.4%

Help With Feelings/Emotions, 3.3%

Experiment/See What It's Like, 2.5%

Because I Am Hooked/Have To Have It, 2.3%

Some Other Reason (Write In Responses), 1.2%

Increase/Decrease Effect of Other Drug, 0.9%


Sources of Pain Relievers for Most RecentMisuse (2015 Data)

* The Other category includes: “Write in responses not already listed in source table” or “Responses with insufficient information that could allow forplacement in another category.”

http://www.samhsa.gov/data/sites/default/files/NSDUH DetTabs 2015/NSDUH DetTabs 2015/NSDUH DetTabs 2015.pdf Table 6.56BAccessed 10/11/2016

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OneDoctor,34%

MoreThan OneDoctor,1.7%

Stole fromDoctor'sOffice,Clinic,Hospital

orPharmacy,

0.7%

ThroughPrescription(s)or Stole FromHealth CareProvider,36.4%

Given orBought or TookFrom a Friendor Relative,

53.7%

Bought FromDrug Dealer orStranger, 4.9%

Some OtherWay, 4.9%

FromFriend or

Relative forFree, 40.5%

Boughtfrom Friendor Relative,

9.4%

Took fromFriend orRelativeWithoutAsking,3.8%


Sources of Pain Relievers for Nonmedical UseBy Frequency of NMU (Combined 2008 2011 Data)

* The Other category includes: "Wrote Fake Prescription," "Stole from Doctor's Office/Clinic/Hospital/Pharmacy," and "Some Other Way."

Sources of Prescription Opioid Pain Relievers by Frequency of Past Year Nonmedical Use: United States, 2008 2011. CM Jones, LJ Paulozzi, KA Mack.JAMA Int Med 174(5):802 3. 2014

0

10

20

30

40

50

60

70

1 29 d 30 99 d 100 199 d 200 365 d

Free: Friend/Relative

Pay: Friend/Relative

Stole: Friend/Relative

Pay: Dealer/Stranger

Rx: Physician(s)

Other

Annual Days of NMU

Percent

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n = ~7.0MM ~2.1MM ~1.1MM~0.8MM

8


0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

http://www.cdc.gov/nchs/data/databriefs/db166_table.pdf#1 Tables 2 and 3http://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000 2014.pdfhttp://www.hhs.gov/blog/2015/12/10/rates of drug overdose deaths continue to rise.html# https://ndews.umd.edu/featuredcontent/1403

Fatal Overdoses Involving Opioids

Benzodiazepines Involved:• 1999 – 527 (13%)• 2011 – 5,188 (31%)

Synthetic Opioids other thanMethadone Involved:• 2014 – 5,544 (29%)• 79% Increase over 2013• Largely non pharmaceutical fentanyl

Methadone Involved:• 1999 – 784 (19.5%)• 2007 – 5,518 (38%)• 2011 – 4,418 (26%)

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http://www.iom.edu/Reports/2011/Relieving Pain in America A Blueprint for Transforming Prevention Care Education Research/Press Release.aspxhttps://nccih.nih.gov/research/results/spotlight/081515 Nahin RL. Estimates of Pain Prevalence and Severity in Adults: United States, 2012. Journal ofPain 16(8):769 780;2015.

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Chronic Pain is Endemic in the U.S.

Institute of Medicine of the National Academies (2011) estimates:

• “About 100 million” adult Americans experience chronic pain

• Cost range of $560 – $635 billion annually

National Health Interview Survey (2012) estimates:

• 126 million adults experience some pain in past 3 months

• 25.3 million adults suffer pain daily• 23.4 million adults experience “a lot” of pain• The 39.8 million adults with themost severe pain were more likely to:

• Have worse health status

• Suffer from disability

• Use more health care


http://www.cdc.gov/vitalsigns/opioid prescribing/ Vital Signs, Opioid Painkiller Prescribing, July 2014http://www.imshealth.com/en/thought leadership/ims institute/reports/use of medicines in the us 2013Medicine use and shifting costs of healthcare:A review of the use of medicines in the United States 2013; IMS Avg. Monthly ER/LA Opioid Analgesic Prevalence – data on file

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US Centers for Disease Control & Prevention (2012)

• 259 MM prescriptions for opioids in 2012

IMS Institute for Healthcare Informatics (2012)

• ~ 75 MM persons prescribed an opioid at least once in 2012

IMS NPA Market Dynamics Monthly Opioid Average (01/16 05/16)

• ~ 13.2 MM persons on immediate release (IR) opioid analgesic

• ~ 1.7 MM persons on extended release or long acting (ER/LA) opioid

Opioid Prescriptions in the U.S.

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The Federal SolutionWhite House Office of National Drug Control Policy (ONDCP)

• Rx Drug Abuse Policy Approach Is Built on Four Pillars:– Education – Prescribers and consumers– Monitoring – PDMPs and clinical monitoring of progress– Disposal – Take back programs and FDA instructions in FPIs– Enforcement – Existing laws against trafficking and pill mills

• FDA to perform expedited review of NDAs for:– analgesics with no abuse potential– abuse deterrent formulations for:

o opioid medications ando other drugs with abuse potential

• FDA to provide guidance to industry on development andassessment of potentially abuse deterrent drug formulations2

http://www.whitehouse.gov/sites/default/files/ondcp/issues content/prescription drugs/rx_abuse_plan.pdfhttp://www.whitehouse.gov/sites/default/files/ondcp/policy and research/ndcs_2014.pdf

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• “FDA considers the development of these products a high publichealth priority.”

• Delineates four Categories of studies that can characterize productattributes as abuse deterrent.

• Defines “meaningful” deterrence as the standard for label claims• States that no absolute performance thresholds on studies• States that science of abuse deterrence technology and its

evaluation is relatively new and continually evolving.• Abuse Deterrent Properties and Claims will:

– Generally be based on results from studies in more than one Category– Include caveats about abuse by:

o The route(s)/method(s) of abuse it deterso Other routes/methods of abuse

Guidance for Industry Abuse Deterrent Opioids — Evaluation and Labeling Issued by Food and Drug AdministrationFinal Guidance issued April 2015 at : http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf

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Abuse Deterrent Opioids—Evaluation and Labeling

Guidance to Industry (April 2015)


Common Methods of Abuse

*Mechanically compromised = break, crush, grind, mill, etc.

† Intravenous or subcutaneous

Adapted from: Katz N et al. Tampering with prescription opioids: nature and extent of the problem, health consequences, and solutions. AmJ Drug Alcohol Abuse. 2011; 37:205 217.

Route Dosage Form Manipulation (if any)

Oral Intact dosage form(s) swallowed

Chewed dosage form(s) swallowed

Extract from dosage form(s) swallowed (eg, EtOH, water)

Inhaled Intact or mechanically compromised* dosage form(s) vaporized

Mechanically compromised dosage form(s) inspired into nasal cavity

Injection†Mechanically compromised dosage form(s) dissolved, usually with aid ofheat, aspirated into syringe, and injected

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Technological Approaches to AbuseDeterrence

FDA Draft Guidance for Industry Abuse Deterrent Opioids — Evaluation and Labeling. January 2013.Alexander, L. et al. Development and impact of prescription opioid abuse deterrent formulation technologies. Drug Alcohol Depend. (2014),http://dx.dio.org/10.1016.j.drugalcdep.2014.02.006 (2014)

Technology Description

Physical/ChemicalBarriers

Physical barriers: can prevent chewing, crushing, cutting, grating, or grinding.Chemical barriers: can resist extraction of the opioid using common solvents like water,alcohol, or other organic solvents.These barriers can limit drug release after manipulation or change the form of the drug,rendering less amenable to abuse

Agonist/AntagonistCombinations

Antagonist added to interfere with, reduce, or defeat the euphoria associated with abuse.Antagonist may be sequestered and released only upon manipulation of the product, ie,antagonist is not clinically active when the product is swallowed but becomes active if theproduct is crushed and injected or snorted.

AversionSubstances can be combined to produce an unpleasant effect if the dosage form ismanipulated prior to ingestion or a higher dosage than directed used.

Delivery SystemCertain drug release designs or the method of drug delivery can offer resistance to abuse,eg, sustained release IM depot formulation or a subcutaneous implant.

NewMolecular Entities& Prodrugs

NME could cross BBB slowly, have atypical receptor occupancy profile, etc. Prodrugs lackopioid activity until transformed in the gastrointestinal tract and can be unattractive forintravenous injection or intranasal routes of abuse.

Combination Two or more of the above methods can be combined to deter abuse.

Novel Approaches Approaches or technologies that are not captured in the previous categories.

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Evaluation of Abuse Deterrence(Study Categories Numbered per FDA Guidance)


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Premarket Studies

1 In Vitro Manipulation & ExtractionEvaluate the ease of defeating physical andchemical properties of the formulation

2

3

PharmacokineticsCompare PK profiles of intact and manipulatedproduct with those of a suitable comparator

Clinical Abuse PotentialAssess abuse related measures(eg, drug liking, willingness to take again)

EpidemiologyAssess real world impact using postmarketingoutcomes data

Postmarket Studies

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Hypothetical Abuse Deterrent Properties and Claims


Results from Studies in Category 1

[Tradename] has physical and chemical propertiesexpected to deter intravenous abuse.

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Results from Studies in Categories 1 & 2

[Tradename] has physical and chemical propertiesthat are expected to deter oral, nasal, and intravenous

abuse.

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Results from Studies in Categories 2 & 3

PK data demonstrate crushing results in rapidabsorption of the opioid and antagonist. These, with

results of clinical abuse potential studies, show[Tradename] has properties expected to deter oral,

nasal, and intravenous abuse.

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Results from Studies in Category 4

These data demonstrated reduced abuse of[Tradename] in the community, which appears

attributable to its formulation, which deters nasal andintravenous abuse.

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Label Claims Also Include Caveats


• Examples could include:

– [Tradename] has physical and chemical properties expected todeter crushing the tablet. However, [Tradename] can still beabused by swallowing intact tablets.

– [Tradename] has properties expected to deter abuse by theoral, intranasal, and intravenous routes. However, abuse of[Tradename] by these routes is still possible.

– Additional data, including epidemiological data, when available,may provide further information on the impact of[Tradename] on the abuse liability of the drug in thecommunity. Accordingly, this section may be updated in thefuture as appropriate.

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Abuse Deterrent Properties and Claims


Appear in Section 9.2 of a product’s FPI (or “Label”) when:

1) The drug product has attributes intended to discourage its abuse

that have undergone the studies specified by the FDA

AND

2) The results of those studies show that the drug product:

– can be expected to result in or has demonstrated ameaningfulreduction in its abuse.

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Abuse Deterrent Properties and Claims inFPIs


9. DRUG ABUSE AND DEPENDENCE

9.2 Abuse

Descriptions of selected study design, conduct, and results

Abuse Deterrence Properties and Claims currently appear inthe Summary at the end of Section 9.2

Note: Abuse Deterrent Properties in Section 9.2 of an FPI does NOTmean the product is abuse proof.

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DailyMedThe official provider of FDA approved Full Prescribing Information (FPI) for Human and Animal Drug Products and

Biologics

https://dailymed.nlm.nih.gov/dailymed/index.cfm Screen capture 06/21/2016

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Abuse Deterrent PropertiesDrugs@FDA

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

The FDA approval history of drug products now has separate bulleted designationif FDA has determined that a product has abuse deterrent properties.

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[Tradename]

[Tradename,sponsor, and otherinformation will behere]


Approved Opioids*With Technology Designed to Impart Abuse Deterrence**

Technology Active Ingredients in Drug Products


ER: hydrocodone (2); hydromorphone; morphine; oxycodone (2);oxycodone + APAP; oxymorphone; tapentadol

Agonist AntagonistCombinations

ER: morphine + naltrexone; oxycodone + naloxoneIR: buprenorphine + naloxone† (multiple); pentazocine + naloxone

Aversion IR: diphenoxylate + atropine††

Delivery System ER: buprenorphine†

Prodrug

Combination IR: oxycodone (physical + aversive agent)

* Not all opioid drug products are indicated for use as analgesics, eg:† Indication: use in Opioid Dependence (ie, Opioid Addiction)†† Indication: Antidiarrheal

** Not all have Labeled Abuse Deterrence Properties and Claims

Alexander, L. et al. Development and impact of prescription opioid abuse deterrent formulation technologies.Drug Alcohol Depend. 138:1 6 (2014). http://www.sciencedirect.com/science/article/pii/S0376871614000611 and specific product’s FPIs

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NB: Information Currentas of 10/10/2016

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“in Development,” as used here, includes drug substances or products that are the subject of preclinical development, Investigational NewDrug applications, New Drug Applications, or Abbreviated New Drug Applications

Technology Active Ingredients in Drug Products


ER: levorphanol; morphine; oxycodone; oxymorphone; tapentadol

Agonist AntagonistCombinations

ER: oxycodone + naltrexone (sequestered)

Aversion IR: oxycodone + aversive agent; oxycodone/APAP + aversive agent

Delivery System ER: hydromorphone

ProdrugER: hydrocodone; hydromorphoneIR: hydrocodone; hydromorphone

Combination IR: oxycodone (physical) + aversive agent

New Chemical Entity MOR agonist with slow crossing of BBB

Opioids in DevelopmentWith Technology Designed to Impart Abuse Deterrence

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Physical/Chemical Barriers Example

• Polyethylene oxide (high MW)

• Heat and pressure during manufacturing process

Difficult to crush: physicalbarrier to obtaining finepowder.

Hard to dissolve: if mixed withliquid, it turns into a viscousgel.

http://www.fda.gov/downloads/AdvisoryCommittees/Committees MeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM233243.pdf Accessed 03/12/2015

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Physical/Chemical Barriers(selected example)

• Drug substance binds to inactive constituents (fatty acid, waxes)within microspheres that fill a capsule.

• Each microsphere has ER properties.

http://www.collegiumpharma.com/technology platform/overview Accessed 03/11/2015

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Agonist/Antagonist Example

• Capsule containing many pellets

• Each pellet contains ER morphine sulfate surrounding a sequesteredcore of IR naltrexone

Rate controlling membrane

Morphine sulfate

Sequestering membrane

Naltrexone

Pellets are between 1.0 1.7 mm dia.

Modified from: https://www1.pfizerpro.com/hcp/embeda/technology Accessed 03/11/2015

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Agonist/Antagonist (selected example)

• Capsule contains beads

• Some beads contain ER oxycodone

• Some beads contain sequestered IRnaltrexone

• Beads are same size, color, weight,and density

• Crushing, dissolving, or extractingreleases both oxycodone andnaltrexone, blunting or preventingeuphoria from opioid agonist

Modified from: http://www.elitepharma.com/how it works/ Accessed 03/11/2015

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Combination

http://acurapharm.com/platforms/aversion technology/ Accessed 03/11/2015

• Gelling agents todeter extraction andintravenous abuse

• Aversive agents todeter intranasalabuse

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Delivery System Example

• Biodegradable, controlledrelease, implant

• Polymer blended with drugsubstance and extruded

• Can be made to have deliverytimes from weeks to months

http://www.titanpharm.com/technology Accessed 10/11/2016

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Prodrug Example

• A drug substance bound to a ligand

• After oral administration, ligand is cleaved away by enzymaticaction/pH, releasing drug substance to exert effects at the receptor

L

Enzyme or pH

DS

Prodrug cannot bind to receptor

L

In vitroligation

DS

Drug binds to receptor

RDS

DrugSubstance

DS

Ligand

L

L

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Draft Guidance for Generic Opioids

General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products – Guidance for Industryat http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM492172.pdf Accessed 10/11/2016 81 FR 69532(October 6, 2016) at https://www.gpo.gov/fdsys/pkg/FR 2016 10 06/pdf/2016 24234.pdf Accessed 10/11/2016

• On March 24, 2016, FDA issued a draft Guidance for generic drugdevelopers intending to submit applications for products that

reference an opioid with abuse deterrent properties.

• Comment period closed May 24, 2016.

• Public Meeting on Pre Market Evaluation of Abuse Deterrent

Properties of Opioid Drug Products – October 31 – November 1,

2016.

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Summary

• OADP will have their maximal public health impact only whensubstantially all opioids have Abuse Deterrent Properties andClaims in their FPIs.

• Abuse deterrent technologies are one part of a comprehensiveintervention strategy to promote safe prescription opioid use

– Additional components, including governmental, community, andeducational initiatives, are also needed.

• Public and private sector policies should encourage the use ofOADP where appropriate, eg:– availability of OADP on drug formularies– removal of barriers to their use:

o higher co payso step edits

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Questions about

• The reasons OADP are important innovations?

• The FDA’s direction to those developing OADP?

• Abuse Deterrent Properties and Claims in FPIs?

• The technologies considered for imparting abusedeterrence to formulations of opioid drug products?

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MR 00139

Kelley Waara Wolleat, PharmD, MBAAssociate Director, Medical Science Liaison

Purdue Pharma L.P.

kelley.waara [email protected]

Contact Information

All rights reserved. © 2015, Purdue Pharma L.P.

Documents

PBA Health PPOK OPHA - · PDF file1 PBA Health ° PPOK ° OPHA Opioids with Abuse‐Deterrent Properties and Claims (OADP) By Kelley Waara‐