Safety and Tolerability of Biphasic Immediate-Release/Extended-Release Oxycodone/Acetaminophen Tablets: Analysis of 11 Clinical Trials

Objectives To characterize the safety of immediate‐release (IR)/extended‐release (ER) oxycodone (OC)/acetaminophen (APAP). Methods Data were assessed from 9 phase 1 trials in healthy volunteers and recreational users of prescription opioids (N = 405), including 5 single‐dose and 3 multidose open‐lab...

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Bibliographic Details
Published in:Pain practice 2016-09, Vol.16 (7), p.856-868
Main Authors: Barrett, Thomas, Kostenbader, Kenneth, Nalamachu, Srinivas, Giuliani, Michael, Young, Jim L.
Format: Article
Language:English
Subjects:
Acetaminophen - administration & dosage
Acetaminophen - adverse effects
acute pain
Adult
Analgesics - administration & dosage
Analgesics - adverse effects
chronic low back pain
Clinical Trials as Topic
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - adverse effects
Drug Combinations
Female
fixed-dose combination
Humans
Male
Middle Aged
opioid analgesic
osteoarthritis
Oxycodone - administration & dosage
Oxycodone - adverse effects
Pain - drug therapy
postoperative pain
Tablets - therapeutic use
tramadol HCl
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Summary:Objectives To characterize the safety of immediate‐release (IR)/extended‐release (ER) oxycodone (OC)/acetaminophen (APAP). Methods Data were assessed from 9 phase 1 trials in healthy volunteers and recreational users of prescription opioids (N = 405), including 5 single‐dose and 3 multidose open‐label pharmacokinetic studies of IR/ER OC/APAP and active comparators; and 1 randomized, controlled, single‐dose human abuse potential (HAP) study comparing IR/ER OC/APAP, IR OC/APAP, and placebo in recreational users of opioids; and 2 phase 3 trials (N = 701) including a 48‐hour placebo‐controlled safety and efficacy study in patients with moderate to severe postbunionectomy pain with a 14‐day open‐label safety extension and a long‐term (≤ 35 days) open‐label safety study in patients with chronic osteoarthritis pain or chronic low back pain. Results Adverse events (AEs) experienced by ≥ 10% of participants receiving IR/ER OC/APAP in all trials were pruritus, nausea, vomiting, dizziness, headache, and somnolence; these AEs occurred with similar frequency for equianalgesic doses of IR OC/APAP and IR OC but less frequently for IR tramadol HCl/APAP. In the HAP study, crushing IR/ER or IR OC/APAP tablets did not increase frequency of AEs. Constipation was experienced by
ISSN:1530-7085
1533-2500
DOI:10.1111/papr.12324