Rx15 general wed_800_revised4-6_volkow rx drug summit 2015 final ndv3

Rx Drug Abuse Where is Science Leading Us?

Nora D. Volkow, M.D.Director

Analgesic Mechanisms of Mu Opiate Drugs(Heroin, Vicodin, Morphine)

Pain

Ascendinginput

Descending modulation

Dorsalhorn

Dorsal rootganglion

Peripheralnerve

SpinothalmicTract

Peripheral nociceptors

Trauma

OpioidsAlpha2 agonists

Local anestheticsAnti-inflammatorydrugs

Local anestheticsOpioidsAlpha2 agonists

Local anesthetics

Thalamus(pain)

ACC(pain)

PAG(pain)

Accumbens(reward)

Numbers in Millions

Prescription Drug Misuse/Abuse is a Major Problem in the US

Source: SAMHSA, 2013 National Survey on Drug Use and Health, 2014.

0.3

0.5

1.3

1.5

6.5

19.8

24.6

0 10 20 30

Heroin

Inhalants

Hallucinogens

Cocaine

Psychotherapeutics

Marijuana

Illicit Drugs4.7

4.95.1 5

4.8 4.9 4.8

4.3

4.8

4.2

2.1 2.2 2.1 2.1 22.2 2.2

22.3

2

1.2 1.11.4

1.2 1.1 1.2 1.1 11.3 1.3

0.3 0.3 0.4 0.3 0.2 0.3 0.40.2 0.2 0.2

0

1

2

3

4

5

6

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Current Drug Use Rates in Persons Ages 12+

Per

cen

t

Past Year Nonmedical Use of Types of Psychotherapeutic Drugs among

Persons Aged 12 or Older: 2004-2013

High Levels of Opioid Prescriptions have Facilitated Diversion of Opioids and Contributed to Overdose Deaths

4,0304,400

5,528

7,456

8,517

9,857

10,928

13,72314,408

14,80015,597

16,65116,917

16,00716,235

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

Rx Opioid Overdose Deaths Total Female Male

Source: CDC Wonder

Oxycodone and Hydrocodone Prescriptions

16 19 22 25 27 29 31 34 3843 47 49

54 57 57

7283

9096

101106 110

120126

132 133 130 131136 134

0

20

40

60

80

100

120

140

160

Mil

lions

Oxycodone (Schedule II)Hydrocodone…

SDI Health, VONA_02-1-13_Opioids Schedule II & III

Past Month &Past Year Heroin Use Persons Aged 12 or Older

SAMHSA, 2012 National Survey on Drug Use and Health, 2014.

404

314

398379

560

373

455

582621 620

669 681

166

119

166136

339

161

213193

239281

335289

0

100

200

300

400

500

600

700

800

200220032004200520062007200820092010201120122013

Past Year

Past Month

Nu

mb

ers

in T

ho

usa

nd

s

1,960 1,842 1,7792,089 2,080

1,878 2,009 2,0882,399

3,0413,278

3,036

4,397

5,925

8,257

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

Heroin Overdose Deaths Total Female Male

Source: CDC Wonder

Abuse of Opioid Medications has led to a Rise in Heroin Abuse and Associated Deaths from Overdoses

How Can Research Help?

• PAIN: Develop less abusable analgesics and

alternative therapeutics

• OVERDOSES: User Friendly Naloxone

• ADDICTION: New Medications and Immunotherapies

• Pharmacogenomics (precision medicine)

• Implementation science

Abuse-Resistant Opioid Prodrug(i.e., Signature Therapeutics)

PAIN: Less Abusable Analgesics

Technologies For Invasive & Non-invasive Neuromodulation

Transcranial Direct Current Simulation (tDCS)

passes direct current thoughtwo electrodes

High-Definition transcranialDirect Current Stimulation (HD-

tDCS) uses arrays of scalp electrode to guide current to brain structures

Morena-Duarte I et al., Neuroimage 2014; 85(3): 1003-1013.

Non-Medication StrategiesFor the Treatment of PAIN and ADDICTION

Left sensory thalamusLeft periventricular gray

Gray AM et al., J Pain

2014; 15(3): 283-292.

Deep Brain Stimulation (DBS)Stereotaxtic implantation of

electrodes that emit electrical stimulation to a targeted

neuronal region

Transcranial Magnetic Stimulation (TMS)

Magnets induce current in the brain

NIDA-Sponsored User Friendly Naloxone (nasal spray)

• AntiOp, developing a single-dose, disposablenaloxone nasal spray • Investigational New Drug (IND) application

filed in 2012 • Product could be on the market 2015

• Lightlake Therapeutics, conducting clinical trialswith intranasal naloxone for binge eating disorder will test this technology for the treatment of opioidoverdose • Clinical trials began 2012

Opioid Agonist Treatments Decreased Heroin OD Deaths

Baltimore, Maryland, 1995-2009

# O

ver

do

se D

eath

s

# P

ati

ents

Tre

ate

d

Heroin overdoses

Buprenorphine patients

Methadone patients

RCT of Buprenorphine Implants compared with Placebo & Sublingual

Buprenorphine/Naloxone for Opioid Addiction

Rosenthal RN et al., Addiction 2013;105: 2141-2149.

Buprenorphine Implants

% of Urines Negative (out of 72) for Opioids Across Weeks 1 to 24%

of

Pati

ents

Fa

ilin

g t

o E

xce

ed

Ea

ch P

oss

ible

Cri

teri

on

of

Su

cces

s

PlaceboSublingual Buprenorphine

Challenge: Compliance with daily intake

Solution: Can one develop long acting medications

Schwartz RP et al., Am J Public Health 2013.

Heroin Anti-Heroin Antibodies

Developing Vaccines to Block Heroin’s Effects

HEROIN CAN NOT ENTER THE BRAINHEROIN RAPIDLY ENTERS THE BRAIN

• Responsible Prescribing and Managementof Chronic Pain, which requires enhanced Education on Pain and its Treatment

• Availability of Naloxone

• Mandatory Addiction Education in Medical,Nursing and Pharmacy Schools

Strategies that Can Help Address the Dangers of Opioid Overdose and Addiction in the US

National Pain Strategy

”HHS Secretary

should develop a

comprehensive,

population health-

level strategy for

pain prevention,

treatment,

management,

education,

reimbursement

and research ..."

ORWHOBSSRNIDANIDCRNINDS

NIANINRNICHDNIAMSNCCIH

NIH Pain Consortium Centers of Excellence in Pain Education

Goal: Improve pain treatmentthrough education

25%9%

17%9%

16% 19%

0%10%20%30%40%50%60%70%80%90%

100%

% Treatment Programs

Offering FDA-approved

SUD Medications

Methadone26.4%

Buprenorphine3.9%

Vivitrol0.3%

Not receiving Methadone,

Buprenorphine, or Vivitrol

69.4%

% OTP patients receiving methadone, buprenorphine, or

vivitrol

Knudsen et al, 2011, J Addict Med

• NIDA CoEs established in 2007 to help fill gaps in medical education curricula related to both illicit drugsand Rx drug abuse

• Medical schools at CoEs have developed a diverse portfolio of innovative curriculum resources about how to identify and treatpatients struggling with SUD

Resources for Medical Students, Resident Physicians & Faculty

NIDA

Questions

Rx15 general wed_800_revised4-6_volkow rx drug summit 2015 final ndv3

Healthcare

Transcript of Rx15 general wed_800_revised4-6_volkow rx drug summit 2015 final ndv3