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
Nov 15, 2014
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®.
2
Core
Please see full Prescribing Information available at this event.
INTRODUCTION TO NUCYNTA®
3
Core
Please see full Prescribing Information available at this event.
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
4
Core
Please see full Prescribing Information available at this event.
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
5
Core
Please see full Prescribing Information available at this event.
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
6
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.
Core
Please see full Prescribing Information available at this event.
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
7
PAIN STIMULUS
– Acetaminophen
– NSAIDs
– Anticonvulsant drugs
– Opioids
– Local anesthetics
– Tricyclic antidepressants
– Serotonin/norepinephrine reuptake inhibitors
– Anticonvulsant drugs
– Opioids
Core
Please see full Prescribing Information available at this event.
DUAL MECHANISM OF ACTION: NOREPINEPHRINE REUPTAKE INHIBITOR
AND µ-OPIOID RECEPTOR AGONIST
8
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*+
-
Core
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)
Please see full Prescribing Information available at this event.
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
Core
Please see full Prescribing Information available at this event.
• 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
Core
Please see full Prescribing Information available at this event.11
NUCYNTA®: PHASE 3 CLINICAL DATA
Core
Please see full Prescribing Information available at this event.
TAPENTADOL IR TRIAL DATA:
STUDIED IN MORE THAN 3000 PATIENTS
12
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
Core
Please see full Prescribing Information available at this event.
END-STAGE JOINT DISEASE OF THE HIP OR KNEE STUDY:
ANALGESIC EFFICACY IN A 10-DAY TRIAL
13
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*† *†
Core
*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.
Please see full Prescribing Information available at this event.14
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
Core
*P<.001 vs placebo. † Both doses of tapentadol IR were noninferior to oxycodone IR 10 mg.
Please see full Prescribing Information available at this event.
END-STAGE JOINT DISEASE OF THEHIP OR KNEE STUDY:
TREATMENT-EMERGENT ADVERSE EVENTS REPORTED BY ≥1% OF SUBJECTS1,2
15
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
Core
Please see full Prescribing Information available at this event.
BUNIONECTOMY STUDIES: TREATMENT-EMERGENT ADVERSE EVENTS
REPORTED BY ≥5% OF SUBJECTS
16
*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
Core
Please see full Prescribing Information available at this event.
END-STAGE JOINT DISEASE OF THE HIP OR KNEE STUDY:
COMPOSITE INCIDENCE OF NAUSEA AND/OR VOMITING1,2
17
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 (
%)
*
*
Core
Please see full Prescribing Information available at this event.
BUNIONECTOMY STUDY II: COMPOSITE INCIDENCE OF NAUSEA
AND/OR VOMITING1,2
18
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 (
%)
*
* †
Core
Please see full Prescribing Information available at this event.
90-DAY SAFETY STUDY: TREATMENT-EMERGENT ADVERSE EVENTS
REPORTED BY ≥2% OF SUBJECTS
19
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
Core
Please see full Prescribing Information available at this event.
NAUSEA AND VOMITING RATES AMONG OPIOID-NAÏVE* VS OPIOID-EXPERIENCED†
PATIENTS IN THE 90-DAY STUDY
20
*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†
Core
Please see full Prescribing Information available at this event.
DISCONTINUATION RATES DUE TO ADVERSE EVENTS IN STUDIES ≥10 DAYS:
EVENTS REPORTED IN ≥2% OF PATIENTS*
21
*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
Core
(Blanks indicate <2% incidence or adverse event not reported)
Please see full Prescribing Information available at this event.
IMPORTANT SAFETY INFORMATION
22
• 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.
Core
Please see full Prescribing Information available at this event.
IMPORTANT SAFETY INFORMATION
(cont)
23
• 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.
Core
Please see full Prescribing Information available at this event.
IMPORTANT SAFETY INFORMATION
(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.
24
Core
Please see full Prescribing Information available at this event.
IMPORTANT SAFETY INFORMATION
(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.
25
Core
Please see full Prescribing Information available at this event.
IMPORTANT SAFETY INFORMATION
(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.
26
Core
Please see full Prescribing Information available at this event.
IMPORTANT SAFETY INFORMATION
(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®.
27
Core
Please see full Prescribing Information available at this event.
IMPORTANT SAFETY INFORMATION
(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.
28
Core
Please see full Prescribing Information available at this event.29
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
Core
Please see full Prescribing Information available at this event.30
Case Studies
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
•Low Back Pain
•Postoperative Pain
•Neck Pain
•Lower Abdominal Pain
CASE STUDIES
32
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Potential Option: NUCYNTA®
PATIENT PROFILE: BARBARA
38
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Potential Option: NUCYNTA®
PATIENT PROFILE: STEPHEN
41
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Please see full Prescribing Information available at this event.
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
Potential Option: NUCYNTA®
PATIENT PROFILE: KEN
44