Safety profile of EMBEDA morphine sulfate and

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					Katz N, Setnik B, Webster L, et al.
Safety profile of EMBEDA™ (morphine sulfate and naltrexone hydrochloride)
Extended Release Capsules in older patients
29th Annual Scientific Meeting of the American Pain Society (APS) (Baltimore, MD: May
6, 2010)
American Geriatrics Society guidelines suggest opioid use for moderate-to-severe pain in
carefullyselected older patients.1 Used as directed EMBEDA™ capsules, containing pellets
of extendedrelease morphine with a sequestered naltrexone core, provide relief from
chronic, moderate-tosevere pain.2 If tampered by crushing, a common method of abuse,
naltrexone is released to mitigate the morphine-induced subjective effects opioid abusers
seek. There were 115 patients aged ≥65y in two phase-III clinical trials studying
EMBEDATM: Trial-A, a placebo-controlled study to assess 12-wk maintenance of
analgesia (dose-titration for all patients, followed by randomization, with double-blind,
double-dummy forced taper over 2wk for patients randomized to placebo) and Trial-B, an
open-label study to assess safety for up to 12 months. Here we report safety assessments,
including incidence of adverse events (AEs), shifts in clinical laboratory values, and signs
and symptoms of withdrawal using the Clinical Opiate Withdrawal Scale (COWS, 0-48
score, none-severe) in patients aged at least 65y. In Trial-A, overall AE incidence in
patients randomized to EMBEDATM was 52.5% (74/141) in patients <65y and 56.7%
(17/30) in those ≥65y; in those randomized to placebo, rates were 50% (68/136) and 43.2%
(16/37), respectively. In Trial-B, overall AE incidence was 82.3% (343/417) in younger
patients and 72.9% (35/48) in older patients. Notable differences in individual AEs (Trial-
A [EMBEDA,<65y/EMBEDA, ≥65y/placebo,<65y/placebo,≥65y]: abdominal pain upper
[5.0%/0.0%/2.9%/0.0%], chills [1.4%/6.7%/2.2%/8.1%], anorexia
[1.4%/6.7%/0.0%/2.7%], osteoarthritis [0.0%/6.7%/0.0%/0.0%]; Trial-B: fatigue [<65y:7.
0%,/≥65y: 0.0%], headache [<65y:13. 2%/≥65y:2.1%]) were not considered clinically
important, nor were differences in shifts in clinical laboratory results or mean change from
baseline in COWS. Results indicate that older patients participating in these studies did not
experience an appreciable difference in treatmentemergent AEs, shifts in laboratory values,
or occurrence of withdrawal syndrome when compared with younger patients. (Supported
by King Pharmaceuticals®, Inc.) (1. AGS Panel, J Am Geriatr Soc, 2009; 2. EMBEDA
Prescribing Information, 2009.)

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