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Pain Medicine 2014; 15: 1365–1372
Wiley Periodicals, Inc.
Aberrant Drug-Related Behavior Observed
During a 12-Week Open-Label
Extension Period of a Study Involving
Patients Taking Chronic Opioid Therapy for
Persistent Pain and Fentanyl Buccal Tablet
or Traditional Short-Acting Opioid for
Breakthrough Pain
Steven D. Passik, PhD,* Arvind Narayana,
MD, MBA,† and Ronghua Yang, PhD†
paring fentanyl buccal tablet and immediate-release
oxycodone for treatment of breakthrough pain.
*Clinical Addiction Research and Education,
Millennium Research Institute, San Diego, California;
†
Teva Pharmaceuticals, Frazer, Pennsylvania, USA
Methods. Patients were rerandomized to continue treatment with fentanyl buccal tablet or begin
any traditional short-acting opioid. Assessments
included Screener and Opioid Assessment for
Patients with Pain-Revised (SOAPP-R) at baseline
and Addiction Behaviors Checklist and Current
Opioid Misuse Measure at baseline and final visit.
Case report forms were reviewed retrospectively to
identify aberrant drug-related behaviors.
Reprint requests to: Steven D. Passik, PhD, Clinical
Addiction Research and Education, Millennium
Research Institute, 16980 Via Tazon, San Diego, CA
92127, USA. Tel: 317-796-2673; Fax: 858-217-8514;
E-mail: [email protected].
Disclosures/Conflicts of Interest: S.D. Passik has
nothing to disclose. A. Narayana and R. Yang are
employees of Teva Pharmaceuticals.
Abstract
Objective. Evaluate aberrant drug-related behaviors
in patients administering fentanyl buccal tablet or
traditional short-acting opioids for breakthrough
pain.
Design. Twelve-week open-label extension.
Setting. Forty-two US sites.
Subjects. Opioid-tolerant patients with chronic
pain who completed the previous randomized,
double-blind, crossover portion of a study com-
Results. One hundred thirty patients entered the
open-label extension (fentanyl buccal tablet,
N = 65; traditional short-acting opioid, N = 65).
SOAPP-R scores were <18 (low risk of aberrant
drug-related behavior) in 74% of patients; no significant differences in SOAPP-R scores were
observed between treatment groups. At the final
visit, ≤14% of patients in each treatment group had
scores indicating potential aberrant drug-related
behavior (Addiction Behaviors Checklist ≥3, Current Opioid Misuse Measure ≥9); no significant
differences in scores were observed between
treatment groups. Baseline SOAPP-R score ≥18
was not predictive of Addiction Behaviors Checklist ≥3 but was predictive of Current Opioid Misuse
Measure ≥9. Aberrant behaviors were identified
in 12 (18%) fentanyl buccal tablet patients and 13
(20%) traditional short-acting opioid patients.
Conclusions. Incidence of aberrant drug-related
behaviors was similar between patients taking
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Passik et al.
fentanyl buccal tablet and traditional short-acting
opioids over 12 weeks.
Key Words. Aberrant Behavior; Breakthrough Pain;
Chronic Pain; Fentanyl Buccal Tablet; Opioid; Risk
Assessment
The objective of this analysis was to evaluate and
compare occurrences of aberrant drug-related behaviors
in patients administering fentanyl buccal tablet or a traditional oral short-acting opioid for BTP over 12 weeks
of open-label treatment. The value of pretreatment risk
assessment was also investigated.
Methods
Introduction
Study Design and Patients
Opioids are widely used for the treatment of moderate to severe chronic, persistent pain [1–3]. Inappropriate use of prescription opioids is a growing problem
that can complicate pain management and lead to
misuse, abuse, diversion, addiction, and other serious
problems [4,5]. Aberrant behavior is defined as drugseeking behavior and/or problematic opioid use and is
sometimes associated with addictive disease [6]. In
studies of real-world patients with chronic pain who were
monitored for 1 year, opioid misuse or aberrant behaviors occurred in 32–41% [4,7].
Opioid-tolerant patients with chronic pain who completed
the randomized, double-blind, active-controlled, crossover portion of the study comparing the efficacy and
safety of fentanyl buccal tablet (FENTORA/EFFENTORA,
Teva Pharmaceuticals, Frazer, PA, USA) with immediaterelease oxycodone for BTP were eligible to enroll in this
12-week open-label extension period. Details of the study
design and primary results have previously been reported
[12]. The study was conducted at 42 sites in the United
States from December 2008 to November 2009 (http://
www.ClinicalTrials.gov, NCT00813488). The protocol was
approved by an institutional review board or independent
ethics committee at each study site, and all study procedures were conducted in accordance with good clinical
practice [15]. Written informed consent was obtained from
all patients before study enrollment.
Information on the misuse, abuse, addiction, or diversion
of opioids in the clinical study setting is limited. The majority of data published to date is from the clinical practice
setting. A need exists for additional information on
methods to identify and predict the risk of aberrant drugrelated behaviors before and after initiation of opioid
therapy to help guide appropriate clinical use of these
agents [8].
Fentanyl buccal tablet is a rapid-onset opioid indicated
for the management of breakthrough pain (BTP) in
cancer patients who are opioid tolerant [9,10]. A randomized, double-blind, active-controlled crossover study
with a 12-week open-label extension period evaluated
the efficacy and safety of fentanyl buccal tablet vs
a traditional short-acting opioid (immediate-release
oxycodone) in opioid-tolerant patients with chronic pain
who were experiencing BTP [11]. Treatment with fentanyl
buccal tablet was associated with a rapid onset of analgesia, with significant differences in pain intensity as
early as 10 minutes and in any pain relief as early as 15
minutes postdose [11]. After the 12-week open-label
treatment extension phase, patients and clinicians
reported consistently better functional improvement and
satisfaction with fentanyl buccal tablet than with traditional short-acting opioids [12].
Various factors are involved in the assessment of risk of
abuse and misuse. Limited data suggest that a faster
rate of increase in blood levels may contribute to greater
drug abuse liability [13]. However, there have been
no controlled studies in chronic pain to support this
theory. It is believed that many other factors, such as
genetic predisposition (specific opioid receptor binding/
interaction features and other neurobiological factors
that influence behavior), dose, patient history, and
environment, may also have an impact on abuse or
misuse [14].
1366
Men and women between 18 and 80 years of age were
eligible for the study if they 1) had a ≥3 months history of
chronic pain; 2) were opioid tolerant (i.e., were taking at
least 60 mg/day of oral morphine or the equivalent of
another opioid as an around-the-clock opioid for ≥1 week
before study entry); 3) had an average pain intensity score
of ≤6 on an 11-point numeric rating scale (0 = no pain,
10 = worse pain imaginable); and 4) were experiencing
one to four episodes of BTP per day (lasting <4 hours on
average) and were achieving at least partial relief with
opioids for their BTP. Patients with uncontrolled or rapidly
escalating pain that was not BTP or with a recent history
(≤5 years) of substance abuse were excluded from the
study [11,12].
Patients entering the open-label extension period were
randomized to continue treatment with fentanyl buccal
tablet at the successful dose identified during the previous
double-blind portion of the study or to begin treatment
with any traditional short-acting opioid, as determined for
each patient to be the standard of care by their treating
physician. Patients randomized to fentanyl buccal tablet
were not permitted to use any other supplemental medication but were allowed to take a second dose of fentanyl
buccal tablet if, after 30 minutes, relief of the BTP episode
was insufficient. Patients were instructed to treat no more
than six BTP episodes per day with no more than eight
doses of fentanyl buccal tablet per day. Patients randomized to a traditional short-acting opioid were permitted to
take any supplemental medication prescribed by their
physician (with the exception of oral transmucosal
fentanyl citrate and fentanyl buccal tablet). Patients in
both treatment groups continued administering their
Aberrant Behaviors and Fentanyl Buccal Tablet
around-the-clock medication throughout the study.
Around-the-clock medication could have been changed
at any time during the open-label extension period if
clinically indicated.
study medication) [7,19–21] also were identified through a
retrospective review of data from case report forms.
Statistical Analysis
Several risk management strategies were employed in the
study. Study medication was counted at visits 7, 8, and 9,
and investigators were responsible for maintaining drug
accountability records. Urine drug screenings were performed at screening and at each visit during the openlabel extension period (visits 6, 7, 8, and 9), as well as
unannounced at any time during the study at the discretion of the investigator.
Assessments
The Screener and Opioid Assessment for Patients With
Pain-Revised (SOAPP-R) was used to assess the effectiveness of screening for each patient’s risk of developing
an aberrant drug-related behavior at baseline of the
overall study. The questionnaire consists of 24 questions
that address eight concepts: substance abuse history,
medication-related behaviors, antisocial behaviors/history,
psychosocial problems, psychiatric history, doctor–patient
relationship factors, emotional attachment to pain medications, and personal care and lifestyle issues [16].
Patients rated answers on a 5-point scale (0 = never,
1 = seldom, 2 = sometimes, 3 = often, and 4 = very
often), with the total possible score ranging from 0 to 96.
Scores ≥18 were used to classify patients at potentially
higher risk for an aberrant drug-related behavior [16].
The Addiction Behaviors Checklist (ABC) was used to
evaluate aberrant behaviors and behaviors characteristic
of addiction related to prescription opioid medications
[17]. Investigators completed the ABC at baseline and
visits 6, 7, 8, and 9 (final visit, week 12, or upon early
termination of the study). The ABC total score was calculated using the 20 items on the checklist. Each affirmative
response was counted as 1 point, and the total score
could range from 0 to 20. Patients with a total score ≥3
were classified as exhibiting inappropriate medication use
during the study.
The Current Opioid Misuse Measure (COMM) was also
used to evaluate aberrant behaviors [18]. Patients completed the COMM at baseline and visits 6, 7, 8, and 9 (final
visit). Answers to the 17 questions on the COMM were
rated on a 5-point scale (0 = never, 1 = seldom, 2 = sometimes, 3 = often, and 4 = very often), with the total score
ranging from 0 to 68. Patients with a total score ≥9 were
classified as exhibiting aberrant drug-related behavior.
To determine the relationship between aberrant drugrelated behaviors and prospective risk assessment, the
ABC and COMM scores were analyzed at the final visit of
the open-label extension period according to SOAPP-R
scores at baseline.
Occurrences of clinically documented aberrant behaviors
(e.g., positive urine drug screening results, lost or stolen
The open-label safety analysis set, which included all
patients who administered at least one dose of the study
medication during the open-label extension period, was
used for all aberrant behavior analyses. Data for the
SOAPP-R, ABC, and COMM were summarized using
descriptive statistics. To determine the utility of prospective risk assessment for the prediction of actual aberrant
drug-related behaviors, Pearson’s two-sided chi-squared
test was used to test the change from baseline for ABC
and COMM total scores (categorized) at each visit for
patients whose baseline SOAPP-R total score was <18
and ≥18, separately.
Results
Patient Disposition and Demographics
A total of 131 patients entered the open-label extension
period. Of these, 130 (99%) received treatment (fentanyl
buccal tablet, N = 65; traditional short-acting opioid,
N = 65) and were included in the safety analysis set, and
112 (85%) completed the open-label extension period
(fentanyl buccal tablet, N = 53; traditional short-acting
opioid, N = 59). The majority of patients (68%) randomized
to a traditional short-acting opioid received immediaterelease oxycodone.
Patient demographics and other baseline characteristics,
which are summarized in Table 1, were generally similar
between treatment groups. The traditional short-acting
opioid group had a slightly greater percentage of men
(45% vs 38%) and a slightly lower age (49.4 vs 51.8
years), both potential predictors of increased risk of aberrant drug-related behavior. On the other hand, the fentanyl
buccal tablet group had a greater percentage of patients
at baseline with a COMM score ≥9 (16% vs 9%), as well as
a greater percentage of patients with a baseline SOAPP-R
score ≥18 (29% vs 23%). Thus, overall, at baseline, it does
not appear that one group was at a clearly higher risk for
aberrant drug-related behaviors.
Twelve patients in the fentanyl buccal tablet group did
not complete the open-label extension period because
of noncompliance with study drug administration (N = 4),
lack of study medication efficacy (N = 3), noncompliance
with study procedures (N = 2), an adverse event
(esophageal mass, N = 1), protocol violation (N = 1), or
other reason (N = 1). Seven patients receiving a traditional short-acting opioid did not complete the openlabel period because of an adverse event (N = 2
[myoclonus, N = 1; pneumonia aspiration, N = 1]), protocol violation (N = 2), withdrawal of informed consent
(N = 2), or noncompliance with study procedures
(N = 1).
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Passik et al.
Table 1 Baseline demographics and clinical characteristics: open-label safety analysis set
Fentanyl Buccal
Tablet (N = 65)
Age, years
Mean (SD)
Gender, N (%)
Male
Female
Race, N (%)
White
Black
Other
Weight, kg
Mean (SD)
Height, cm
Mean (SD)
Body mass index, kg/m2
Mean (SD)
Primary diagnosis of chronic pain, N (%)
Back pain
Neck pain
Osteoarthritis
Traumatic injury
Fibromyalgia
Cancer
Complex regional pain syndrome
Diabetic peripheral neuropathy
Postherpetic neuralgia
Rheumatoid arthritis
Other
Traditional Short-Acting
Opioid (N = 65)
51.8 (9.6)
49.4 (10.0)
25 (38)
40 (62)
29 (45)
36 (55)
61 (94)
3 (5)
1 (2)
57 (88)
6 (9)
2 (3)
89.9 (25.4)
83.4 (21.6)
170.3 (9.8)
170.1 (10.0)
30.9 (7.9)
28.5 (6.3)
38 (58)
5 (8)
7 (11)
5 (8)
2 (3)
2 (3)
1 (2)
0
0
1 (2)
4 (6)
46 (71)
7 (11)
3 (5)
0
2 (3)
0
1 (2)
2 (3)
1 (2)
0
3 (5)
SD = standard deviation.
Aberrant Behavior Assessments
The mean total SOAPP-R score in the safety analysis set
was 14.0 (range 2.0–43.0), with a mean (standard deviation) SOAPP-R score of 14.4 (8.5) in patients administering fentanyl buccal tablet and 13.6 (7.4) in patients
administered a traditional short-acting opioid. The majority
of all patients in the study (74%) had an SOAPP-R score
<18. The distribution of the SOAPP-R scores using this
cutoff value was similar when comparing patients administering fentanyl buccal tablet (71%) and those administering a traditional short-acting opioid (77%).
Overall, the mean total ABC score at the final visit was 0.2
(range 0–4), and the mean total COMM score was 3.5
(range 0–23). No clinically meaningful changes in the ABC
or COMM questionnaire total scores from baseline to endpoint were observed in either treatment group (Table 2).
No statistically significant differences between the fentanyl
buccal tablet group and the traditional short-acting opioid
group were observed; for total ABC score, the least
squares (LS) mean difference between the fentanyl buccal
tablet group and the traditional short-acting opioid group
from baseline to endpoint was 0.01 (95% confidence
interval [CI] −0.2, 0.3; P = 0.9), and for total COMM score,
1368
the LS mean difference was 0.54 (95% CI −0.7, 1.8;
P = 0.4). The majority of patients had ABC scores <3
(96%) and COMM scores <9 (89%) at endpoint, suggesting that most patients did not exhibit aberrant drug-related
behaviors at the end of the study.
The proportion of patients with ABC scores <3 and ≥3 by
treatment and baseline SOAPP-R score and the proportion of patients with COMM scores <9 and ≥9 by treatment and baseline SOAPP-R score are summarized in
Table 3. There were no significant differences in the proportion of patients with ABC scores <3 and ≥3 and COMM
scores <9 and ≥9 between treatment groups when stratified by baseline SOAPP-R scores <18 vs ≥18 (P ≥ 0.3).
However, significantly more patients with baseline
SOAPP-R score ≥18 had COMM score ≥9 at baseline
(P < 0.0001) and endpoint (P = 0.03) (Table 4).
Aberrant behaviors were identified in 12 (18%) patients
administering fentanyl buccal tablet and in 13 (20%)
administering a traditional short-acting opioid. Two or
more aberrant behaviors were identified for five patients
(four administering fentanyl buccal tablet and one administering a traditional short-acting opioid). Five (42%)
patients with aberrant behaviors administering fentanyl
Aberrant Behaviors and Fentanyl Buccal Tablet
Table 2 ABC scores and COMM questionnaire scores by treatment
ABC Scores*
Mean score (SD)
Baseline
Visit 6
Visit 7
Visit 8
Visit 9
Endpoint
ABC <3 or COMM <9, N (%)
Baseline
Endpoint
ABC ≥3 or COMM ≥9, N (%)
Baseline
Endpoint
COMM Scores*
Fentanyl Buccal
Tablet (N = 65)
Traditional
Short-Acting
Opioid (N = 65)
Fentanyl Buccal
Tablet (N = 65)
Traditional
Short-Acting
Opioid (N = 65)
0.2 (0.48)
0.1 (0.46)
0.2 (0.50)
0.2 (0.54)
0.1 (0.52)
0.2 (0.77)
0.1 (0.43)
0.2 (0.51)
0.2 (0.60)
0.2 (0.60)
0.2 (0.73)
0.2 (0.70)
4.4 (4.21)
3.7 (2.99)
3.3 (3.10)
3.2 (2.86)
3.5 (3.87)
4.0 (4.09)
3.5 (4.07)
3.6 (3.91)
3.5 (3.96)
3.0 (3.47)
2.9 (4.12)
3.0 (4.24)
65 (100)
62 (95)
65 (100)
63 (97)
54 (84)
56 (86)
58 (91)
60 (92)
10 (16)
9 (14)
6 (9)
5 (8)
0
3 (5)
0
2 (3)
* Fentanyl buccal tablet vs traditional short-acting opioid therapy comparison (all P ≥ 0.3).
ABC = Addiction Behaviors Checklist; COMM = Current Opioid Misuse Measure.
buccal tablet and two (15%) administering a traditional
short-acting opioid had baseline SOAPP-R scores ≥18.
One (8%) patient with aberrant behaviors administering
fentanyl buccal tablet and one (8%) administering a traditional short-acting opioid had ABC scores ≥3 at baseline
or the final visit. Four (33%) patients with aberrant behaviors administering fentanyl buccal tablet and two (15%)
administering a traditional short-acting opioid had COMM
scores ≥9 at baseline or the final visit.
Discussion
This 12-week, randomized, open-label extension period of
a larger randomized, double-blind, crossover study pro-
Table 3 Baseline SOAPP-R vs ABC and COMM questionnaire scores at endpoint by treatment
ABC Scores*
Baseline SOAPP-R <18, N
ABC <3 or COMM <9, N (%)
Baseline
Endpoint
ABC ≥3 or COMM ≥9, N (%)
Baseline
Endpoint
Baseline SOAPP-R ≥ 18, N
ABC <3 or COMM <9, N (%)
Baseline
Endpoint
ABC ≥3 or COMM ≥9, N (%)
Baseline
Endpoint
COMM Scores*
Fentanyl Buccal
Tablet (N = 65)
Traditional
Short-Acting
Opioid (N = 65)
Fentanyl Buccal
Tablet (N = 65)
Traditional
Short-Acting
Opioid (N = 65)
46
50
46
50
46 (100)
44 (96)
50 (100)
49 (98)
43 (96)
42 (91)
48 (96)
47 (94)
0
2 (4)
19
0
1 (2)
15
2 (4)
4 (9)
19
2 (4)
3 (6)
15
19 (100)
18 (95)
15 (100)
14 (93)
11 (58)
14 (74)
11 (73)
13 (87)
8 (42)
5 (26)
4 (27)
2 (13)
0
1 (5)
0
1 (7)
* Fentanyl buccal tablet vs traditional short-acting opioid therapy comparison (all P ≥ 0.3).
ABC = Addiction Behaviors Checklist; COMM = Current Opioid Misuse Measure; SOAPP-R = Screener and Opioid Assessment for
Patients with Pain-Revised.
1369
Passik et al.
Table 4 Baseline SOAPP-R vs ABC and COMM
scores for all patients
Baseline SOAPP-R
<18
(N = 96)
Baseline ABC, N (%)
<3
96 (100)
≥3
0
Endpoint ABC, N (%)
<3
93 (97)
≥3
3 (3)
Baseline COMM, N (%)†
<9
91 (96)
≥9
4 (4)
Endpoint COMM, N (%)
<9
89 (93)
≥9
7 (7)
≥18
(N = 34)
P Value*
34 (100)
0
32 (94)
2 (6)
0.5
22 (65)
12 (35)
<0.0001
27 (79)
7 (21)
0.03
* Association between baseline SOAPP-R score and ABC or
COMM score.
†
N = 95 for baseline SOAPP-R < 18.
ABC = Addiction Behaviors Checklist; COMM = Current Opioid
Misuse Measure; SOAPP-R = Screener and Opioid Assessment for Patients with Pain-Revised.
spectively evaluated the risk and incidence of aberrant
drug-related behaviors in patients administering fentanyl
buccal tablet vs a traditional oral short-acting opioid to
treat BTP. There were no significant differences in ABC or
COMM scores observed between treatment groups, indicating that aberrant drug-related behavior between fentanyl buccal tablet and traditional short-acting opioids was
similar in this study population. Baseline SOAPP-R questionnaire scores were not predictive of aberrant drug use
behaviors when evaluated by ABC and COMM scores at
the final visit.
Despite this study’s selective exclusion criteria, 26% (34/
130) of enrolled patients in this analysis were considered
at high risk for an aberrant behavior (SOAPP-R score ≥18).
Further, although the clinical study population was highly
selected, aberrant drug-related behaviors occurred in
18% of patients administering fentanyl buccal tablet and
20% of patients administering a traditional short-acting
opioid, highlighting the limitations of current screening
methods and the need for active monitoring. Overall, the
incidence of retrospectively analyzed aberrant drugrelated behaviors observed in this analysis was relatively
low, which is consistent with findings from previous pooled
analyses involving fentanyl buccal tablet. In a retrospective
analysis assessing aberrant drug-related behaviors in
1,160 strictly selected predominantly noncancer patients
administering fentanyl buccal tablet for BTP, <1% had an
abuse-related event, <2% had a positive urine drug
screening for an unprescribed drug or illicit substance, 1%
had an event consistent with opioid overdose, and 11%
had an aberrant behavior related to fentanyl buccal tablet
1370
[22]. However, this analysis generally included patients in
open-label studies with no active control group. There
have been no previous studies comparing the frequency
of aberrant drug-related behaviors between rapid-onset
opioids and traditional short-acting opioids. The current
study found no clear signal that patients taking fentanyl
buccal tablet had greater aberrant drug-related behaviors
than those taking a traditional short-acting opioid.
Although clinicians may sometimes focus on the etiology
of chronic pain (e.g., cancer related vs noncancer related)
when determining the risk of aberrant drug-related behaviors [23], assessing the pretreatment risk of aberrant
behavior by SOAPP-R or other screening tools may have
value [8]. In this study, a SOAPP-R score ≥18 at baseline
was not predictive of an ABC score ≥3 but was associated
with a COMM score ≥9. However, relatively fewer patients
had an ABC ≥3, which may have limited the ability of this
study to characterize the relationship between pretreatment SOAPP-R and ABC scores.
Particular attention to patient selection, including a thorough risk assessment, is necessary when initiating opioid
therapy. Fentanyl buccal tablet must be used only for
opioid-tolerant patients; thus, physicians should have a
thorough understanding of the patient’s history and
potential risk factors before therapy with fentanyl buccal
tablet is initiated. Proper patient selection could mitigate
potential risks and enhance potential benefits associated
with opioid therapy for chronic pain [14,24]. In particular,
clinical guidelines emphasize the value of risk stratification
and close monitoring of patients for aberrant drug-related
behaviors consistent with abuse, addition, or diversion [2].
Screening tools based on patient characteristics that
assess the potential risks associated with chronic opioid
therapy are likely to be helpful for risk stratification, but
more studies are needed to understand how these tools
may affect clinical outcomes [2,8]. Additional assessment
methods include urine drug testing, pill counts, family
member or caregiver interviews, and review of prescription
monitoring program data [2].
This study had several limitations. The relatively small
sample size may limit the strength of the conclusions, and
the open-label study design, with no blinding for study
investigators, may have led to bias in the results as it is
possible that the investigator may have changed their
management of an individual patient based on a low or
high score on one of the risk measures employed during
the study. Also, this investigation was performed in a
controlled clinical study setting, with strict eligibility criteria.
Importantly, patients with a recent history (≤5 years) of
substance abuse were excluded from the overall study.
Thus, these data may not be generalizable to the general
clinical population. Patients with a high risk of substance
abuse, as well as current substance abusers, would probably be at a greater risk for aberrant behaviors with a
rapid-onset opioid such as fentanyl buccal tablet relative
to a traditional short-acting opioid. The rate of aberrant
drug-related behaviors in this carefully selected population
was lower than that seen in previous studies of long-term
Aberrant Behaviors and Fentanyl Buccal Tablet
opioid therapy in chronic pain patients (32–50%) [4,7,19].
However, it should be noted that these studies were generally conducted in the real-world setting and typically had
a duration of approximately 1 year, longer than that in the
current analysis. Incorporating some study methodologies
(e.g., specified patient selection criteria, risk stratification,
monitoring) into routine clinical practice may improve outcomes, a notion that is complemented by the increasing
efforts to integrate rigorous risk evaluation and mitigation
strategy programs for patients on chronic opioid therapy
into routine clinical practice.
Conclusions
In this population of patients with no recent history (≤5
years prior to study start) of substance abuse and under
structured care administering opioids for chronic pain,
including BTP, the incidence of aberrant drug-related
behaviors was statistically similar between fentanyl buccal
tablet and traditional short-acting opioids for BTP over the
12-week open-label treatment period. Pretreatment risk
assessment may be helpful in guiding the appropriate
clinical use of these medications, but further study
is required.
Acknowledgments
This study was sponsored by Cephalon, Inc. (Frazer,
Pennsylvania, USA), now a wholly owned subsidiary of
Teva Pharmaceuticals. The authors thank Craig Q. Earl,
PhD, formerly of Teva Pharmaceuticals, for contributions
to study design and data analysis. Writing support was
provided by Peloton Advantage, LLC, funded by Teva
Pharmaceuticals.
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