(+) Single-entity hydrocodone extended-release for chronic pain (PAINWeek 2012) - Sep 7, 2012 - P3, N=424; NCT01115569; Changes in BPI scores from screening to end of treatment showed improvement in pain severity, relief achieved with medication, and interference with activities; HC-ER exhibited a safety profile consistent with that of other opioids and appeared effective for managing chronic pain
P3 data • Pain
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Painweek 2012, 5-8 Sep 12
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Purpose
Hydrocodone
is only available in combination with nonopioid analgesics, such as
acetaminophen, which may prevent titration of hydrocodone to therapeutic
levels. Hydrocodone bitartrate extended-release (HC-ER; ZohydroTM, Zogenix,
Inc., San Diego, CA), the first single-entity hydrocodone formulation, will
provide another option for treatment of moderate-to-severe chronic pain without
the dose-limiting effect of acetaminophen. The overall objective of this study
was to evaluate long-term safety and efficacy of HC-ER in subjects with
moderate-to-severe chronic pain.
Method
This
multicenter, open-label study comprised a conversion/titration (C/T) phase (≤6
weeks) followed by a treatment phase (≤48 weeks) in opioid-experienced subjects
with chronic pain. During C/T, subjects (n=638) were converted to HC-ER using
initial doses 20%-30% less than the equivalent dose calculated by the Opioid
Conversion Table. HC-ER dose was titrated until stabilized. During the
treatment phase, subjects (n=424) received their individualized HC-ER dose and
up to 2 tablets of HC bitartrate 5 mg/acetaminophen 500 mg daily. Safety was
the primary endpoint. Efficacy endpoints included change in pain intensity (PI)
score (0-10 numerical rating scale) and selected Brief Pain Inventory (BPI)
questions about pain severity, relief with medication, and interference with
activities. No statistical testing was performed.
Results
638/938
(68%) of screened subjects were enrolled; 424/638 (66%) and 285/424 (67%)
completed the C/T and treatment phases, respectively. Daily PI score improved
from screening to end of treatment (mean±SD change, -2.3±2.5). Changes in BPI scores from screening
to end of treatment showed improvement in pain severity, relief achieved with
medication, and interference with activities. The most common adverse
events (AEs) during the C/T phase were constipation (72/638; 11%) and nausea
(68/638; 11%). The most common AEs during the treatment phase were constipation
(53/424; 13%) and back pain (47/424; 11%). The most frequent AEs that led to
study discontinuation (DAEs) in the C/T phase were nausea (10/638; 2%),
somnolence (9/638; 1%), insomnia (7/638; 1%), lethargy (7/638; 1%), and
headache (7/638; 1%). The most frequent DAEs in the treatment phase (each
2/424; 0.5%) were constipation, upper abdominal pain, and cognitive disorder.
Four deaths occurred; all were considered unrelated or unlikely to be related
to HC-ER. No trends in laboratory parameters or vital signs were evident.
Conclusions
HC-ER exhibited a safety profile consistent
with that of other opioids and appeared effective for managing chronic pain. HC-ER may provide a
new opioid option for subjects with chronic pain not satisfied with their
current treatment.
IR
8
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