PMID- 27550954
OWN - NLM
STAT- MEDLINE
DCOM- 20180403
LR  - 20191210
IS  - 1526-4637 (Electronic)
IS  - 1526-2375 (Print)
IS  - 1526-2375 (Linking)
VI  - 18
IP  - 6
DP  - 2017 Jun 1
TI  - Abuse Potential Study of ALO-02 (Extended-Release Oxycodone Surrounding 
      Sequestered Naltrexone) Compared with Immediate-Release Oxycodone Administered 
      Orally to Nondependent Recreational Opioid Users.
PG  - 1077-1088
LID - 10.1093/pm/pnw178 [doi]
AB  - OBJECTIVE: To evaluate the abuse potential of ALO-02, an abuse-deterrent 
      formulation comprising pellets of extended-release oxycodone hydrochloride 
      surrounding sequestered naltrexone hydrochloride. DESIGN: Randomized, 
      double-blind, placebo-/active-controlled, 6-way crossover study, with naloxone 
      challenge, drug discrimination, and treatment phases. SUBJECTS: Nondependent, 
      recreational opioid users. METHODS: Oral administration of crushed and intact 
      ALO-02, crushed immediate-release (IR) oxycodone, and placebo. Primary endpoints 
      were Drug Liking and High measured on visual analog scales and reported as 
      maximum effect (E max ) and area-under-the-effect-curve from 0 to 2 hours (AUE 
      0-2h ). Other pharmacodynamic, pharmacokinetic and safety assessments were 
      included. RESULTS: Drug Liking and High (E max ) for crushed oxycodone IR 40 mg 
      were significantly higher compared with placebo, confirming study validity ( P 
       < 0.0001). Drug Liking and High (E max, AUE 0-2h ) for crushed ALO-02 
      (40 mg/4.8 mg and 60 mg/7.2 mg) were significantly lower compared to 
      corresponding doses of crushed oxycodone IR (40 and 60 mg; P  < 0.0001). 
      Likewise, Drug Liking and High (E max and AUE 0-2h ) for intact ALO-02 
      60 mg/7.2 mg were significantly lower compared with crushed oxycodone IR 60 mg ( 
      P  < 0.0001). Secondary pharmacodynamic endpoints and plasma concentrations of 
      oxycodone and naltrexone were consistent with these results. Fewer participants 
      experienced adverse events (AEs) after ALO-02 (crushed or intact: 71.1-91.9%) 
      compared with crushed oxycodone IR (100%). Most common AEs following crushed 
      ALO-02 and oxycodone IR were euphoric mood, pruritus, somnolence, and dizziness. 
      CONCLUSIONS: The results suggest that ALO-02 (crushed or intact) has lower abuse 
      potential than crushed oxycodone IR when administered orally in nondependent, 
      recreational opioid users.
CI  - (c) 2016 American Academy of Pain Medicine.
FAU - Setnik, Beatrice
AU  - Setnik B
AD  - Global Product Development, Global Innovative Pharma - Neuroscience & Pain, 
      Pfizer Inc, Durham, NC, USA.
FAU - Bass, Almasa
AU  - Bass A
AD  - Global Product Development, Global Innovative Pharma - Clinical Sciences, Pfizer 
      Inc, Durham, NC, USA.
FAU - Bramson, Candace
AU  - Bramson C
AD  - Global Product Development, Global Innovative Pharma - Clinical Sciences, Pfizer 
      Inc, Groton, CT, USA.
FAU - Levy-Cooperman, Naama
AU  - Levy-Cooperman N
AD  - Early Phase, INC Research LLC, Toronto, Ontario, Canada.
FAU - Malhotra, Bimal
AU  - Malhotra B
AD  - Global Product Development, Global Innovative Pharma - Clinical Pharmacology, 
      Pfizer Inc, New York, NY, USA.
FAU - Matschke, Kyle
AU  - Matschke K
AD  - Global Product Development, Global Innovative Pharma - Statistics, Pfizer Inc., 
      Collegeville, PA, USA.
FAU - Geoffroy, Pierre
AU  - Geoffroy P
AD  - Early Phase, INC Research LLC, Toronto, Ontario, Canada.
FAU - Sommerville, Kenneth W
AU  - Sommerville KW
AD  - Global Product Development, Global Innovative Pharma - Neuroscience & Pain, 
      Pfizer Inc, Durham, NC, USA.
AD  - Department of Neurology, Duke University Medical Center, Durham, North Carolina, 
      USA.
FAU - Wolfram, Gernot
AU  - Wolfram G
AD  - Global Product Development, Global Innovative Pharma - Neuroscience & Pain, 
      Pfizer Inc, Durham, NC, USA.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Pain Med
JT  - Pain medicine (Malden, Mass.)
JID - 100894201
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Illicit Drugs)
RN  - 0 (Narcotic Antagonists)
RN  - 36B82AMQ7N (Naloxone)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Administration, Oral
MH  - Analgesics, Opioid/*administration & dosage/blood
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations/administration & dosage/metabolism
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - *Illicit Drugs/blood
MH  - Male
MH  - Naloxone/administration & dosage/blood
MH  - Narcotic Antagonists/administration & dosage/blood
MH  - Opioid-Related Disorders/blood/*diagnosis/drug therapy
MH  - Oxycodone/*administration & dosage/blood
PMC - PMC5914361
OTO - NOTNLM
OT  - ALO-02
OT  - Abuse Deterrent
OT  - Abuse Potential
OT  - Opioids
OT  - Oxycodone
EDAT- 2016/08/24 06:00
MHDA- 2018/04/04 06:00
PMCR- 2016/08/19
CRDT- 2016/08/24 06:00
PHST- 2016/08/24 06:00 [pubmed]
PHST- 2018/04/04 06:00 [medline]
PHST- 2016/08/24 06:00 [entrez]
PHST- 2016/08/19 00:00 [pmc-release]
AID - pnw178 [pii]
AID - 10.1093/pm/pnw178 [doi]
PST - ppublish
SO  - Pain Med. 2017 Jun 1;18(6):1077-1088. doi: 10.1093/pm/pnw178.