2010 nucynta core speaker slides

Please see full Prescribing Information available at this event.1

An Advance in Multimodal Analgesic Therapy

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2010 May 2010 02TL10045

Please see full Prescribing Information available at this event.

This promotional educational activity is brought to you by PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, and is not certified for continuing medical education. The speaker is a paid consultant presenting on behalf of PriCara® and must present information in compliance with FDA requirements applicable to PriCara®.

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INTRODUCTION TO NUCYNTA®

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ROLES OF ASCENDING AND DESCENDING PATHWAYS IN PAIN1

1. Woolf CJ. Ann Intern Med. 2004;140(6):441-451.

Pain stimulus1

NOCICEPTIVE INPUT AT

SPINAL CORD1

TRANSMISSION OF PAIN SIGNALS

TO THE BRAIN1

Subjective perception and interpretation of pain

MODULATION OF PAIN VIA DESCENDING INHIBITORY PATHWAYS TO SPINAL CORD1

Ascending Pathways

Descending Pathways

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THE ROLES OF μ-OPIOID AGONISM AND NOREPINEPHRINE (NE) REUPTAKE

INHIBITION

Activation of mu (μ)-opioid receptors in ascending pathways works to inhibit nociceptive signals1

NE reuptake inhibition, which increases the spinal concentration of NE after its release from neurons in the descending pathways, inhibits transmission of pain signals1-3

1. Vanderah TW. Med Clin North Am. 2007;91(1):1-12. 2. Delgado PL. J Clin Psychiatry. 2004;65(suppl 12):16-19. 3. Benarroch EE. Neurology. 2008;71:217-221.

Ascending Pathways

Descending Pathways

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NOREPINEPHRINE (NE): ROLE IN PAIN MODULATION

• The descending inhibitory pathway is a tonically active, important part of the endogenous pain control system1,2

• NE and other monoamines released by the descending pathway modulate pain signaling at spinal and supraspinal levels2-4

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1. Woolf CJ. Ann Intern Med. 2004;140(6):441-451. 2. Pertovaara A. Prog Neurobiol. 2006;80(2):53–83. 3. Vanderah TW. Med Clin North Am. 2007;91(1):1-12. 4. Benarroch EE. Neurology. 2008;71:217-221.

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MECHANISM OF ACTION OF SELECTED ANALGESICS

1. Carver A. In: ACP Medicine. New York, NY: WebMD; 2005:section 11, chap 14. 2. Benarroch EE. Neurology. 2008;71:217-221. 3. Vanderah TW. Med Clin North Am. 2007;91(1):1-12. 4. Knotkova H, Pappagallo M. Med Clin North Am. 2007;91(1):113-124. 5. Becker DE, Reed KL. Anesth Progr. 2006;53:98-109. 6. Tanabe M et al. Brit J Pharmacol. 2005;144(5):703-714.

• Inhibition of pain signal transmission in ascending pathways1-5

• Enhancement of pain modulation by descending pathways2-4,6

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PAIN STIMULUS

– Acetaminophen

– NSAIDs

– Anticonvulsant drugs

– Opioids

– Local anesthetics

– Tricyclic antidepressants

– Serotonin/norepinephrine reuptake inhibitors

– Anticonvulsant drugs

– Opioids

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DUAL MECHANISM OF ACTION: NOREPINEPHRINE REUPTAKE INHIBITOR

AND µ-OPIOID RECEPTOR AGONIST

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1. Tzschentke TM et al. J Pharmacol Exp Ther. 2007;323(1):265-276. 2. Vanderah TW. Med Clin North Am. 2007;91(1):1-12. 3. Pertovaara A. Prog Neurobiology. 2006;80(2):53-83.

Secondary afferentPrimary afferent

Pain signal

Glu+

SP

Ascending pathwayto the brain

Descending pathwayfrom the brain

NE

2-AR

–

μ-OR

Tapentadol*+

-

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Spinal cord

Simplified schematic for mechanism of action.*The exact mechanism of NUCYNTA® (tapentadol) is unknown.

= glutamate (Glu)

= glutamate receptor

= substance P (SP)

= substance P receptor

= norepinephrine (NE)

= alpha2-adrenoceptor (2-AR)

= NE reuptake transporter protein

= mu-opioid receptor (-OR)


SPECIFIC FEATURES

• Indicated for the relief of moderate to severe acute pain in patients 18 years of age or older1

• Centrally acting oral analgesic with dual mechanism of action in 1 chemical entity*1,2:

– Norepinephrine reuptake inhibitor

– mu ()-opioid receptor agonist

• Highlights of pharmacokinetic profile1,3:

– 99% of tapentadol IR and its metabolites are eliminated via renal clearance

– Tapentadol IR has not been shown to induce or inhibit P450 enzymes, and has no active metabolites

• Schedule II1 *The exact mechanism of action of NUCYNTA® is unknown.1. NUCYNTA® (tapentadol) [Prescribing Information]. Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2. Tzschentke TM et al. J Pharmacol Exp Ther. 2007;323(1):265-276. 3. Terlinden R et al. Eur J Drug Metab Pharmacokin. 2007;32(3):163-169. 9

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• The recommended starting dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending on initial pain intensity

• Dosing regimen for NUCYNTA® should be individualized according to– Severity of pain– Previous experience with similar drugs– Ability to monitor patient– Medical history– Concomitant medical therapy

• NUCYNTA® may be administered with or without food

• Dosing recommendations*:

HOW TO DOSE NUCYNTA®

Tablets shown not actual size

Maintain dosing for adequate analgesia andacceptable tolerability

Every 4-6 hours thereafter(maximum 600 mg daily)

If adequate reliefis achieved

If adequate reliefis not achieved

DAY 1NUCYNTA®

50 mg, 75 mg, or 100 mg,depending on pain intensity

Administer seconddose as early as

1 hour later

Every 4-6 hours (maximum 700 mg

on Day 1)

DAY 2 AND BEYONDEvery 4-6 hours

thereafter (maximum600 mg daily)

*For patients with renal/hepatic insufficiency,

please see full Prescribing Information. 10

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NUCYNTA®: PHASE 3 CLINICAL DATA

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TAPENTADOL IR TRIAL DATA:

STUDIED IN MORE THAN 3000 PATIENTS

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OA = osteoarthritis.

*All trials except safety were placebo-controlled.1. Daniels SE et al. Curr Med Res Opin. 2009;25(3):765-776. 2. Daniels S et al. Curr Med Res Opin. 2009;25(6):1551-1561. 3. Hartrick C et al. Clin Ther. 2009;31(2):260-271. 4. Hale M et al. Curr Med Res Opin. 2009;25(5):1095-1104.

Study*No. of

PatientsTapentadol IR

(mg)Oxycodone IR

(mg)Duration

(d)

Bunionectomy I1 603 50, 75, 100 15 3

Bunionectomy II2 901 50, 75 10 3

End-Stage Joint Disease (OA)3 674 50, 75 10 10

90-day Safety4 849 50, 100 10, 15 ≤90

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END-STAGE JOINT DISEASE OF THE HIP OR KNEE STUDY:

ANALGESIC EFFICACY IN A 10-DAY TRIAL

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Intent-to-treat population (N=659; all randomized subjects who received at least 1 study drug intake following randomization and had a valid baseline pain assessment) with a mean baseline pain intensity score of 6.7 was randomized to 50 mg or 75 mg of NUCYNTA®, 10 mg oxycodone IR, or placebo dosed every 4 to 6 hours while patients were awake. The primary efficacy analysis is based on the last observation carried forward (LOCF) imputation method. Adjusted P-values using Hochberg procedure (oxycodone group was not included). SPID is defined as the sum of pain intensity difference and a higher value in SPID indicates greater pain relief.The chart uses the mean SPID calculations vs placebo. These calculations are noted in the original study report. 1. Data on file, J&J PRD, LLC. 2. Hartrick C et al. Clin Ther. 2009;31(2):260-271.

Mean

Cu

mu

lati

ve S

PID

Score

1

Th

e h

igh

er

the S

PID

sco

re,

the g

reate

r th

e p

ain

relie

f

Placebo

Oxycodone IR 10 mg‡

Tapentadol IR 75 mg

Tapentadol IR 50 mg

N=659

130.6

229.2236.5

*

SPID-5 DAYS (Primary Endpoint)0

50

150

250

100

200

223.8*† *†

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*P<.001 for all comparisons vs placebo.1,2

†Both doses of tapentadol IR were noninferior to oxycodone IR 10 mg (prespecified analysis). ‡Clinical trials were conducted with immediate release oxycodone, which is the opioid ingredient in Percocet®, Percodan®, and OxyIR®. Percocet and Percodan are registered trademarks of Endo Pharmaceuticals Inc. OxylR is a registered trademark of Purdue Pharma Inc.


1. Daniels SE et al. Curr Med Res Opin. 2009;25(3):765-776. 2. Daniels S et al. Curr Med Res Opin. 2009;25(6):1551-1561. 3. Data on file, J&J PRD, LLC.

BUNIONECTOMY STUDIES I AND II:ANALGESIC EFFICACY IN A POSTOPERATIVE

PAIN MODEL (3-day trial)M

ean

SP

ID S

core

Placebo

Tapentadol IR 75 mg

Tapentadol IR 50 mg

Oxycodone IR 10 mg

Tapentadol IR 100 mg

0

100

200

50

150

24.5

*119.1

*139.1

*167.2

*172.3

SPID-48 Hours (Primary Endpoint)

54.1

* †122.2

* †143.7

*140.

3

Bunionectomy I (N=602)1 Bunionectomy II (N=901)2,3

Oxycodone IR 15 mg

Th

e h

igh

er

the S

PID

sco

re,

the g

reate

r th

e p

ain

relie

f

Median onset of confirmed, perceptible pain relief with tapentadol IR was as early as 32 to 46 minutes (P≤.005, for all tapentadol IR doses vs placebo onset at 100 min).1 Intent-to-treat population (N=6021 or 9012; all randomized subjects who took at least 1 dose of study medication and had a valid baseline pain assessment) with a mean baseline pain intensity score of 71 or 7.12 was randomized to 50 mg1,2, 75 mg1,2, or 1001 mg of NUCYNTA®, 102 mg or 151 mg oxycodone IR, or placebo dosed every 4 to 6 hours. Based on analysis of covariance model with treatment and study center as factors and baseline pain intensity score as a covariate. Adjusted P-values using Hochberg procedure (oxycodone group was not included). Higher value in SPID indicates greater pain relief.The chart uses the mean SPID calculations vs placebo. These calculations are noted in the original study report.3

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*P<.001 vs placebo. † Both doses of tapentadol IR were noninferior to oxycodone IR 10 mg.


END-STAGE JOINT DISEASE OF THEHIP OR KNEE STUDY:

TREATMENT-EMERGENT ADVERSE EVENTS REPORTED BY ≥1% OF SUBJECTS1,2

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IR = immediate release.*Includes administration site conditions. †Includes subcutaneous tissue disorders.

Adapted with permission from Hartrick C et al.1. Data on file, J&J PRD, LLC. 2. Hartrick C et al. Clin Ther. 2009;31(2):260-271.

System/Organ Class Dictionary-Derived Term

% of Subjects

Placebo(n=169)

Tapentadol IR 50 mg

(n=157)

Tapentadol IR 75 mg

(n=168)

Oxycodone IR 10 mg

(n=172)

GI Disorders 17 29 40 60

Nausea 5 18 21 41

Vomiting 4 7 14 34

Constipation 2 4 7 26

Diarrhea 3 1 5 1

Nervous system disorders 11 29 41 37

Dizziness 5 18 26 23

Somnolence 1 6 10 12

Headache 6 6 8 3

General* 2 6 8 22

Fatigue 1 1 7 10

Skin† 2 6 8 22

Pruritus 1 2 5 15

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BUNIONECTOMY STUDIES: TREATMENT-EMERGENT ADVERSE EVENTS

REPORTED BY ≥5% OF SUBJECTS

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*Dosing: q4-6h per 24 hours (around the clock).

1. Daniels SE et al. Curr Med Res Opin. 2009;25(3):765-776. 2. Daniels S et al. Curr Med Res Opin. 2009;25(6):1551-1561.

(Blanks indicate <5% incidence or adverse event not reported)

Bunionectomy I*1

(3 days)(N=602)

Bunionectomy II*2

(3 days)(N=901)

Placebo NUCYNTA® Oxycodone IR Placebo NUCYNTA® Oxycodone IR

%50 mg

%75 mg

%100 mg

%15 mg

% %50 mg

%75 mg

%10 mg

% Nausea 13 35 38 49 67 17 34 46 57 Vomiting 18 21 32 42 12 28 26 Constipation 7 10 15 8 5 11 Dizziness 5 16 22 31 30 10 15 25 23 Somnolence 12 13 21 10 7 13 12 Headache 7 12 11 12 14 16 20 19 26 Pruritus 9 17 12 5 8 10 Generalized pruritus 7 10 Hyperhydrosis 5 6

Pyrexia 6

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END-STAGE JOINT DISEASE OF THE HIP OR KNEE STUDY:

COMPOSITE INCIDENCE OF NAUSEA AND/OR VOMITING1,2

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Safety population (N=666) with a mean baseline pain intensity score of 6.7 was randomized to 50 mg or 75 mg of NUCYNTA®,10 mg oxycodone IR, or placebo dosed every 4 to 6 hours while patients were awake. Incidence is based on the number of subjects experiencing at least 1 adverse event, not the number of events.IR = immediate release.*P<.001 for both doses of tapentadol IR vs oxycodone IR 10 mg.

1.Hartrick C et al. Clin Ther. 2009;31(2):260-271. 2.Data on file, J&J PRD, LLC.

N=666

8.3%

21.7%

57.0%

29.8%

Composite of Nausea and/or Vomiting

Placebo

Oxycodone IR 10 mg

Tapentadol IR 75 mg

Tapentadol IR 50 mg

0

30

50

60

20

40

10

Incid

en

ce (

%)

*

*

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BUNIONECTOMY STUDY II: COMPOSITE INCIDENCE OF NAUSEA

AND/OR VOMITING1,2

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Intent-to-treat population (N=901) with a mean baseline pain intensity score of 7.1 was randomized to 50 mg or 75 mg of NUCYNTA®, 10 mg oxycodone IR, or placebo dosed every 4 to 6 hours. Incidence is based on the number of subjects experiencing at least 1 adverse event, not the number of events.*P<.001 for all comparisons vs placebo.†P<.001 for tapentadol 50 mg vs oxycodone IR 10 mg (P value adjusted using the Hochberg procedure).

1. Data on file, J&J PRD, LLC. 2. Daniels S et al. Curr Med Res Opin. 2009;25(6):1551-1561.

*

N=901

17.4%

35%

59%

51%

Composite of Nausea and/or Vomiting

Placebo

Oxycodone IR 10 mg

Tapentadol 75 mg

Tapentadol 50 mg

0

30

50

60

20

40

10

Incid

en

ce (

%)

*

* †

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90-DAY SAFETY STUDY: TREATMENT-EMERGENT ADVERSE EVENTS

REPORTED BY ≥2% OF SUBJECTS

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IR = immediate release.

Hale M et al. Curr Med Res Opin. 2009;25(5):1095-1104.

System/Organ Class Dictionary-Derived Term

% of Subjects

Tapentadol IR50 mg or 100 mg

(n=679)

Oxycodone IR10 mg or 15 mg

(n=170)

Gastrointestinal Disorders 44.2 63.5

Nausea 18.4 29.4

Vomiting 16.9 30.0

Constipation 12.8 27.1

Diarrhea 6.6 5.9

Dry mouth 5.3 2.9

Nervous system disorders 36.7 37.1

Dizziness 18.1 17.1

Headache 11.5 10.0

Somnolence 10.2 9.4

Fatigue 5.6 2.4

Skin and tissue 8.5 15.9

Pruritus 4.3 11.8

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NAUSEA AND VOMITING RATES AMONG OPIOID-NAÏVE* VS OPIOID-EXPERIENCED†

PATIENTS IN THE 90-DAY STUDY

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*Opioid use for <5 days/week during the 30 days prior to screening. †Opioid use for ≥5 days/week during the 30 days prior to screening.

1. Hale M et al. Curr Med Res Opin. 2009; 25(5):1095-1104.

18%

39%

14%

23%22%

35%

16%

21%

Incid

en

ce R

ate

s (

%)

40

60

20

50

30

0

10

N=849

Tapentadol IR 50 or 100 mg (n=679)

Oxycodone IR 10 or 15 mg (n=170)

Nausea VomitingOpioid-Naïve*

Nausea VomitingOpioid-Experienced†

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DISCONTINUATION RATES DUE TO ADVERSE EVENTS IN STUDIES ≥10 DAYS:

EVENTS REPORTED IN ≥2% OF PATIENTS*

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*Incidence based on number of subjects, not the number of events. Discontinuation rates include patients who discontinued because of 1 or more adverse events.

†Dosing: q4-6h during waking hours.‡Flexible dosing: q4-6h as needed.IR = immediate release.1. Hartrick C et al. Clin Ther. 2009;31(2):260-271. 2. Hale M et al. Curr Med Res Opin. 2009;25(5):1095-1104.

Feature

End-Stage Joint Disease Study (10 Day) †1

(N=666)

90-Day Safety StudyDisease Study‡2

(N=849)

Placebo NUCYNTA® Oxycodone IR NUCYNTA® Oxycodone IR

%50 mg

%75 mg

%10 mg

%50/100 mg

%10/15 mg

%

Total discontinuation rates due to AEs

4 13 18 30 21 31

NauseaVomitingConstipation

2 4 44

13115

532

1186

DizzinessSomnolenceHeadache

2 72

8

2

96

422

634

Skin Pruritus (itching)

4 2

FatigueAsthenia

22

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(Blanks indicate <2% incidence or adverse event not reported)


IMPORTANT SAFETY INFORMATION

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• Like other drugs with mu-opioid agonist activity, NUCYNTA® is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment. NUCYNTA® is contraindicated in patients who have or are suspected to have paralytic ileus. NUCYNTA® is also contraindicated in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOIs) due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.

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(cont)

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• Respiratory depression is the primary risk of mu-opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. NUCYNTA® should be administered with caution to the elderly, debilitated patients, and patients with conditions accompanied by hypoxia, hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, or coma. In such patients, even usual therapeutic doses of NUCYNTA® may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non-mu-opioid agonist analgesics should be considered and NUCYNTA® should be employed only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any mu-opioid agonist-induced respiratory depression.

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(cont)

• Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with NUCYNTA® may exhibit additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, coma or death may result if these drugs are taken in combination with NUCYNTA®. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.

• Opioid analgesics can raise cerebrospinal fluid pressure as a result of respiratory depression with carbon dioxide retention. Therefore, NUCYNTA® should not be used in patients susceptible to the effects of raised cerebrospinal fluid pressure such as those with head injury and increased intracranial pressure. Opioid analgesics may obscure the clinical course of patients with head injury due to effects on pupillary response and consciousness. NUCYNTA® should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.

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(cont)

• NUCYNTA® is a mu-opioid agonist and is a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty. NUCYNTA® can be abused in a manner similar to other mu-opioid agonists, legal or illicit. This should be considered when prescribing or dispensing NUCYNTA® in situations where the physician or pharmacist is concerned about an increased risk of misuse and abuse. All patients treated with mu-opioid agonists require careful monitoring for signs of abuse and addiction. NUCYNTA® may be abused by crushing, chewing, snorting or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death.

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(cont)

• Experience with NUCYNTA® overdose is very limited. Management of overdose should be focused on treating symptoms of mu-opioid agonism. Primary attention should be given to reestablishment of a patent airway and institution of assisted or controlled ventilation when overdose of NUCYNTA® is suspected. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

• Patients should be cautioned that NUCYNTA® may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This is to be expected especially at the beginning of treatment, at any change of dosage as well as in combination with alcohol or tranquilizers.

• NUCYNTA® has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical studies. NUCYNTA® should be prescribed with care in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.

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(cont)

• The development of a potentially life-threatening serotonin syndrome may occur with use of SNRI products, including NUCYNTA®, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome may include mental-status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, incoordination) and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea).

• Withdrawal symptoms may occur if NUCYNTA® is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Withdrawal symptoms may be reduced by tapering NUCYNTA®.

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(cont)

• Pregnancy Category C. There are no adequate and well-controlled studies of NUCYNTA® in pregnant women. NUCYNTA® should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the fetus. NUCYNTA® is not recommended for use in women during and immediately prior to labor and delivery. Neonates whose mothers have been taking NUCYNTA® should be monitored for respiratory depression. NUCYNTA® should not be used during breastfeeding.

• NUCYNTA® is not recommended in patients with severe renal or hepatic impairment. NUCYNTA® should be used with caution in patients with moderate hepatic impairment. Like other drugs with mu-opioid agonist activity, NUCYNTA® may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.

• The most common adverse events are nausea, dizziness, vomiting, somnolence and headache.

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SUMMARY

• The first new molecule in analgesia in over 25 years for the relief of moderate to severe acute pain in patients 18 years of age or older– Single Molecule

• Combining norepinephrine reuptake inhibition and mu-opioid agonism activity in one centrally acting oral analgesic

– Opioid Efficacy

• Efficacy of NUCYNTA® 50 mg and 75 mg demonstrated across multiple pain models

– GI Tolerability Profile

• Low composite incidence of nausea and/or vomiting with NUCYNTA® 50 mg

– Proven Safety Profile

• Low discontinuation rates due to adverse events

– Pharmacokinetic Profile

• NUCYNTA® has not been shown to inhibit or induce P450 enzymes, and has no active metabolites

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Case Studies


Take a careful pain history• Onset, timing, intensity, location, aggravating or relieving factors, associated symptoms

Assess the quality of pain symptoms

Evaluate the response(s) to current and prior treatments

Assess the patient’s physical and psychological function

Consider relevant medical and drug history

Perform complete medical and neurologic exam • Order new diagnostics, as necessary

Discuss realistic patient expectations and goalsAdapted with permission from Carver 2005.

Carver A. In: ACP Medicine. New York, NY: WedMD; 2005:section 11, chap 14.

PRINCIPLES OF PAIN ASSESSMENT

Assess the quality of pain symptoms

31


•Low Back Pain

•Postoperative Pain

•Neck Pain

•Lower Abdominal Pain

CASE STUDIES

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Age: 40

Gender: Male

Ethnicity: African American

Occupation: Police Officer

Present Complaints:– Hurt his back in a bad fall while at

work, experiencing sharp pain in his lower back with intermittent episodes of dullness, tingling, and aching that radiate down to his toes

– Having difficulty walking and bending

– Has self-medicated with over-the-counter (OTC) pain relievers, but has found no pain relief

PATIENT PROFILE: DAVID*†

*Not an actual patient.

†Patients with acute lower back pain were studied in the phase 3 clinical trials for NUCYNTA®. NUCYNTA® is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. 33


Pain Intensity Rating: Severe—8 (on a scale of 0-10)

Duration of Pain: 5 days

Past Medical History: No relevant medical or surgical history

Medications: OTC pain relievers

PATIENT PROFILE: DAVID

34


Medical Conclusion: – X-ray and MRI of the lumbar spine showed a small disk

herniation at L4,5

– Low back pain with small L4,5 disk herniation associated with probable radiculopathy

Treatment Considerations: – Choose an efficacious agent for optimal acute pain control– Treat pain by addressing both ascending and descending

pathways

Potential Option: NUCYNTA®

PATIENT PROFILE: DAVID

35


Age: 62

Gender: Female

Ethnicity: Caucasian

Occupation: Retired Teacher

Present Complaint:– Currently experiencing stabbing acute

pain in the surgical area (right hip) that is sometimes sharp and associated with burning

– Scar and surrounding area are also tender to touch with no evidence of infection/inflammation

PATIENT PROFILE: BARBARA*†

*Not an actual patient. †Patients with acute pain following hip replacement surgery were not specifically studied in the phase 3 clinical trials for NUCYNTA®.NUCYNTA® is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.

36


Pain Intensity Rating: Severe—8 (on a scale of 0-10)

Duration of Pain: 3 weeks

Past Medical History: – Recently underwent hip replacement surgery for

osteoarthritis of the hip– Given a short-acting opioid (SAO) in the hospital, but

experienced intolerable nausea and discontinued treatment– Did not fill SAO prescription due to her recent experience

with side effects– Has relied solely on over-the-counter (OTC) medications for

pain relief

Medications: Various OTC nonsteroidal anti-inflammatory drugs

PATIENT PROFILE: BARBARA

37


Medical Conclusion: – Continues to experience residual acute pain following

surgery

Treatment Considerations: – Choose an efficacious agent for optimal acute pain control– Minimize opioid-related side effects– Treat pain by addressing both ascending and descending

pathways


PATIENT PROFILE: BARBARA

38


Age: 34

Gender: Male

Ethnicity: Caucasian

Occupation: Mechanic

Present Complaint:– Sharp pain and stiffness in neck– Recently began experiencing

tingling pain radiating to his shoulders and arms

PATIENT PROFILE: STEPHEN*†

*Not an actual patient. †Patients with acute neck pain were not specifically studied in the phase 3 clinical trials for NUCYNTA®. NUCYNTA® is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.

39


Pain Intensity Rating: Moderate—7 (on a scale of 0-10)

Duration of Pain: 2 months

Past Medical History:

– Injured his neck (level C4,5) in a motorcycle accident

– X-rays and MRI scan of cervical spine were normal– Prescribed a short-acting opioid (SAO) during and after

hospital discharge– Nausea caused by SAO was intolerable– Currently self-medicating with over-the-counter (OTC)

medications for relief

Medications: Various OTC nonsteroidal anti-inflammatory drugs

PATIENT PROFILE: STEPHEN

40


Medical Conclusion: – Continues to have acute neck pain with referral into the

shoulders

Treatment Considerations: – Choose an efficacious agent for optimal acute pain control– Minimize opioid-related side effects– Treat pain by addressing both ascending and descending

pathways


PATIENT PROFILE: STEPHEN

41


Age: 60

Gender: Male

Ethnicity: Asian

Occupation: College Professor

Present Complaint:– Experiencing severe sharp, episodic

acute pain in the lower abdomen

PATIENT PROFILE: KEN*†

*Not an actual patient. †Acute pain in patients with cancer was not specifically studied in the phase 3 clinical trials for NUCYNTA®; these patients were excluded from pivotal studies. NUCYNTA® is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. 42


Pain Intensity Rating: Severe—7 to 8 (on a scale of 0-10)

Duration of Pain: One month

Past Medical History:– Diagnosed with colon cancer and just completed a course of

chemotherapy– Was started on an opioid treatment, but discontinued a

week later due to severe nausea and vomiting– Currently taking a COX-II inhibitor and over-the-counter

(OTC) medications to manage pain

Medications: COX-II inhibitor, OTC pain relievers

PATIENT PROFILE: KEN

43


Medical Conclusion:– Needs treatment for continuing episodic acute pain in the

lower abdomen

Treatment Considerations: – Effective pain relief with a proven GI tolerability profile– Treat pain by addressing both ascending and descending

pathways


PATIENT PROFILE: KEN

44

2010 nucynta core speaker slides

Health & Medicine

pain stimulus

severeacute pain

nucynta core

transmission of pain

med clin north

brain ne

descendinginhibitory

transmissionof pain