PMID- 21075272
OWN - NLM
STAT- MEDLINE
DCOM- 20110225
LR  - 20220317
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Linking)
VI  - 40
IP  - 5
DP  - 2010 Nov
TI  - Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride 
      extended release capsules, a novel formulation containing morphine and 
      sequestered naltrexone, in patients with chronic, moderate to severe pain.
PG  - 734-46
LID - 10.1016/j.jpainsymman.2010.05.004 [doi]
AB  - CONTEXT: Morphine sulfate and naltrexone hydrochloride extended release capsules 
      contain extended-release pellets of morphine with a sequestered naltrexone core 
      (MS-sNT). Taken whole, as intended, morphine is released to provide pain relief; 
      if tampered with by crushing, naltrexone is released to mitigate subjective 
      effects of morphine. OBJECTIVES: This open-label study assessed long-term 
      (12-month) safety of MS-sNT in patients with chronic, moderate to severe pain. 
      METHODS: Safety assessments included determining adverse events (AEs), laboratory 
      assessments, and the Clinical Opiate Withdrawal Scale (COWS). Analgesic efficacy 
      was assessed (diary) as worst, least, average, and current pain using an 11-point 
      numeric scale (0=none; 10=worst). RESULTS: Of 465 patients receiving one or more 
      doses, 160 completed the study. Most patients (81.3%) experienced one or more 
      AEs, most commonly constipation (31.8%) or nausea (25.2%). Thirty-three patients 
      (7.1%) reported serious AEs; one patient's severe gastrointestinal inflammation 
      and colitis were considered possibly study drug-related. Most discontinuations 
      (30%) occurred in the first month, most often because of AEs (23.7%). There were 
      no clinically relevant changes in laboratory results or vital signs, and no 
      clinically significant electrocardiogram changes deemed study drug-related. 
      During each visit after Week 1, 5% or fewer patients had COWS scores indicating 
      mild withdrawal symptoms (range, 0%-4.8%). Five patients, who did not take the 
      study drug as instructed, had scores consistent with moderate withdrawal. MS-sNT 
      yielded statistically significant improvements from baseline in mean scores for 
      all pain diary items for all visits, except Week 1 for least pain. CONCLUSION: In 
      this study population, when MS-sNT was taken as directed for chronic, moderate to 
      severe pain for up to 12 months, most AEs were typical opioid-related side 
      effects. Mean COWS scores remained low, indicating lack of withdrawal symptoms 
      and appropriate transition off the study drug at completion.
CI  - Copyright (c) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. 
      All rights reserved.
FAU - Webster, Lynn R
AU  - Webster LR
AD  - Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah 84106, USA. 
      lynnw@lifetreepain.com
FAU - Brewer, Randall
AU  - Brewer R
FAU - Wang, Chao
AU  - Wang C
FAU - Sekora, Doreen
AU  - Sekora D
FAU - Johnson, Franklin K
AU  - Johnson FK
FAU - Morris, David
AU  - Morris D
FAU - Stauffer, Joseph
AU  - Stauffer J
LA  - eng
SI  - ClinicalTrials.gov/NCT00415597
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Drug Combinations)
RN  - 0 (Narcotic Antagonists)
RN  - 5S6W795CQM (Naltrexone)
RN  - 76I7G6D29C (Morphine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/administration & dosage/adverse effects
MH  - Chronic Disease/drug therapy
MH  - Constipation/chemically induced
MH  - Delayed-Action Preparations
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Morphine/*administration & dosage/adverse effects
MH  - Naltrexone/*administration & dosage/adverse effects
MH  - Narcotic Antagonists/administration & dosage/adverse effects
MH  - Nausea/chemically induced
MH  - Pain/*drug therapy
MH  - Pain Measurement/drug effects
MH  - Treatment Outcome
EDAT- 2010/11/16 06:00
MHDA- 2011/02/26 06:00
CRDT- 2010/11/16 06:00
PHST- 2009/12/23 00:00 [received]
PHST- 2010/05/05 00:00 [revised]
PHST- 2010/05/06 00:00 [accepted]
PHST- 2010/11/16 06:00 [entrez]
PHST- 2010/11/16 06:00 [pubmed]
PHST- 2011/02/26 06:00 [medline]
AID - S0885-3924(10)00571-3 [pii]
AID - 10.1016/j.jpainsymman.2010.05.004 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2010 Nov;40(5):734-46. doi: 
      10.1016/j.jpainsymman.2010.05.004.