Single-Entity Hydrocodone Extended-Release Capsules in Opioid-Tolerant Subjects with Moderate-to-Severe Chronic Low Back Pain: A Randomized Double-Blind, Placebo-Controlled Study

Rauck, Richard; Nalamachu, Srinivas; Wild, James; Walker, George S.; Robinson, Cynthia Y.; Davis, Charles S.; Farr, Stephen J.

doi:10.1111/pme.12377

Cited by 47 publications

(53 citation statements)

References 19 publications

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“…There was drug accountability with record keeping of drug administered and drug returned. Another study by Rauck et al [28] looked at the safety and efficacy of HC-ER tablets (Zohydro Ò ER; Zogenix, Inc., San Diego, CA, USA) in the relief of moderate to severe low back pain in opioid-experienced subjects. It was concluded that HC-ER is more effective than placebo as an analgesic and the tolerability and efficacy was maintained during the 12-week period of double-blind treatment.…”

Section: Zohydro Er òmentioning

confidence: 98%

The Clinical Applications of Extended-Release Abuse-Deterrent Opioids

Vadivelu¹,

Schermer²,

Kodumudi³

et al. 2016

CNS Drugs

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Opioids are the mainstay for treatment of acute pain and cancer pain, and also have a role in the treatment of chronic non-malignant pain. There has been, however, a growing public health problem stemming from the misuse of opioid analgesics leading to serious consequences. To deter abuse, new formulations of extended-release opioid analgesics and tamper-resistant opioids have recently been developed. The concept of abuse-deterrent extended-release opioids is relatively new and, although abuse may not be completely prevented, the utilization of such abuse-deterrent extended-release opioids could reduce this risk. Extended-release abuse-deterrent opioids have been found to have important clinical applications in cancer, acute pain, and chronic non-malignant pain for analgesia control with decreased incidence of tampering and abuse. In this review, different extended-release formulations of opioids available for clinical applications are presented with descriptions of the formulations, their physical properties, and the clinical studies performed to provide physicians with a better understanding of their uses.

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Section: Zohydro Er òmentioning

confidence: 98%

The Clinical Applications of Extended-Release Abuse-Deterrent Opioids

Vadivelu¹,

Schermer²,

Kodumudi³

et al. 2016

CNS Drugs

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“…Rauck, et al [34] The mean change from screening to day 85 in SGAM (Subject Global Assessment of Medication) was 0.8 ± 1.3 for the HC-ER (hydrocodone extended release) group compared with 0.0 ± 1.4 for the placebo group (P < 0.001), indicating a significantly greater degree of satisfaction with HC-ER than with placebo.…”

Section: Chownmentioning

confidence: 99%

“…Others were randomised controlled trials (33%, n=9) [15,17,18,[31][32][33][34][35][36], before and after studies (11%, n=3) [37], and cross-sectional surveys (7%, n=2) [5,38].…”

Section: Designmentioning

confidence: 99%

“…Notable examples included questionnaires based on Cherkin & McCornack's satisfaction questionnaire using a 5-point Likert-type scale [19,28], as well as 15 studies that used different types of a single global satisfaction item [15][16][17]20,[24][25][26]30,31,[34][35][36][37]42,43]. Even global satisfaction items were very diverse as they often focused on different aspects of CLBP and its treatment.…”

Section: Questionnaires Used To Measure Patient Satisfaction With Trementioning

confidence: 99%

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Treatment Satisfaction and Dissatisfaction in Chronic Low Back Pain: a Systematic Review

Rofail¹,

Myers²

2016

J Psychol Psychother

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“…The committee also commented on the lack of data presented by Zogenix (Zohydro's manufacturer and sponsor of the clinical trials presented to the FDA) that could contribute to the characterization the responders in the study group, or facilitate the identification of responders in the general population. One committee member emphasized that the indication sought for approvalmoderate-to-severe chronic pain -was a generalized indication that gave prescribers no additional information or grounds for identifying the patients for which the drug would actually be effective, even though 41 per cent of those initially enrolled in the study were discontinued for poor tolerance or inadequate response, followed by an additional 18 per cent of those in the treatment arm of the study (Rauck et al, 2014;ClinicalTrials.gov, 2014).…”

Section: "Unsettling Circularity"mentioning

confidence: 99%

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

Campbell

King

2017

BioSocieties

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The US Food and Drug Administration's approval of the controversial analgesic Zohydro has drawn attention to its endorsement of so-called 'enrichment strategies' for streamlining clinical trials. Among these is 'enriched enrollment randomized withdrawal' (EERW), a design intended to improve measures of drug efficacy by screening out patients who are non-responsive or suffer adverse effects. EERW has been promoted as a response to the problem of high trial failure rates for drugs that were previously thought to be effective for pain management. This article uses EERW as a window into the evidentiary politics of pain medicine in the twenty-first century, against the backdrop of concerns about prescription opioid abuse. We demonstrate that the reframing of negative trials as 'failed' trials poses a challenge to the evidence hierarchy of evidence-based medicine, and identify several rhetorical strategies used by proponents to normalize EERW by placing it in continuity with routine clinical trial practice and the promise of personalized medicine. Finally, we illustrate how EERW, in the current regulatory context, fails to contribute to the individualization of diagnosis or therapy, and reinforces the perceived gulf between trials for regulatory approval and clinical practice.

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Single-Entity Hydrocodone Extended-Release Capsules in Opioid-Tolerant Subjects with Moderate-to-Severe Chronic Low Back Pain: A Randomized Double-Blind, Placebo-Controlled Study

Abstract: Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP.

Cited by 47 publications

References 19 publications

The Clinical Applications of Extended-Release Abuse-Deterrent Opioids

The Clinical Applications of Extended-Release Abuse-Deterrent Opioids

Treatment Satisfaction and Dissatisfaction in Chronic Low Back Pain: a Systematic Review

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

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