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

Webster, Lynn R.; Brewer, Randall P.; Wang, Chao; Sekora, Doreen; Johnson, Franklin K.; Morris, David; Stauffer, Joseph W.

doi:10.1016/j.jpainsymman.2010.05.004

Cited by 34 publications

(53 citation statements)

References 31 publications

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“…Most of the 465 patients (81.3 %) experienced one or more adverse events, most commonly constipation (31.8%) or nausea (25.2%). Opiate withdrawal symptoms were mild and affected < 5% of patients during each week of the study (29). Form these data the authors concluded that combination does not resolve OBD.…”

Section: Naltrexone Extended Releasementioning

confidence: 87%

Opioid Induced Constipation

Aurilio¹,

Pace²,

Pota³

et al. 2012

Constipation - Causes, Diagnosis and Treatment

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Section: Naltrexone Extended Releasementioning

confidence: 87%

Opioid Induced Constipation

Aurilio¹,

Pace²,

Pota³

et al. 2012

Constipation - Causes, Diagnosis and Treatment

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“…Sufficient naltrexone can be released to precipitate withdrawal in opioiddependent individuals, raising concerns among physicians and regulators [Ruan et al 2010;Setnik et al 2013;US FDA, 2013a]. Combining morphine and naltrexone has been reported to provide analgesic efficacy with a good safety profile and reduction in drug likability [Pfizer Inc., 2009;Stauffer et al 2009;Katz et al 2010aKatz et al , 2010bWebster et al 2010Webster et al , 2011Johnson et al 2012]. At the time of writing this article, the marketed morphine + naltrexone product has been withdrawn from the market due to stability problems.…”

Section: Morphine + Naltrexonementioning

confidence: 99%

“…Safety. Long-term safety of morphine + naltrexone was evaluated in a 52-week phase III study [Webster et al 2010]. A total of 465 subjects received at least one dose of study drug, with 65.7% prematurely discontinuing from the study due to adverse event (23.7%), noncompliance (13.7%) or lack of efficacy (8.4%).…”

Section: Morphine + Naltrexonementioning

confidence: 99%

Opioid formulations with sequestered naltrexone: a perspective review

Taylor

Raffa

Pergolizzi

2014

Therapeutic Advances in Drug Safety

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In response to good-intentioned efforts to correct the traditional undertreatment of pain, opioid prescribing experienced a dramatic increase over the past decade. But there is now concern that the pendulum has swung too far in the opposite direction, with a rise in morbidity and mortality associated with prescription opioid misuse and abuse. Yet despite potential problems, opioids are a mainstay for the treatment of pain and are an important component of a comprehensive pain management strategy. Therefore, the overall goal of pain management is to decrease pain and to improve patient functioning and quality of life, while monitoring for adverse effects or aberrant behaviors. That is, to balance effective chronic pain management with appropriate use of opioids. Toward this end, several abuse deterrent strategies (formulations) have been, and continue to be, developed. Several major ones are reviewed here. These products should be a first step in trying to address diversion and abuse in a manner that does not discriminate against any particular patient and aligns with universal prescribing precautions. They should also comprise only one aspect of an overall opioid risk management plan.

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“…87 During clinical trials, Embeda has not been associated with severe withdrawal symptoms when taken as intended 79,88 or after chewing. 87 However, it should be noted that in clinical practice, Embeda has been associated with at least 2 published case reports of acute opioid withdrawal after either accidental or deliberate chewing.…”

Section: Sequestered Opioid Antagonistsmentioning

confidence: 99%

Strategies to Reduce the Tampering and Subsequent Abuse of Long-acting Opioids: Potential Risks and Benefits of Formulations With Physical or Pharmacologic Deterrents to Tampering

Stanos

Bruckenthal

Barkin

2012

Mayo Clinic Proceedings

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Increased prescribing of opioid analgesics for chronic noncancer pain may reflect acceptance that opioid benefits outweigh risks of adverse events for a broadening array of indications and patient populations; however, a parallel increase in the abuse, misuse, and diversion of prescription opioids has resulted. There is an urgent need to reduce opioid tampering and subsequent abuse without creating barriers to safe, effective analgesia. Similar to the "magic bullet" concept of antibiotic development (kill the bacteria without harming the patient), the idea behind reformulating opioid analgesics is to make them more difficult to tamper with and abuse by drug abusers but innocuous to the compliant patient. As antibiotics exploit differences in bacterial and human physiology, tamper-resistant formulations depend on differences in the way drug abusers and compliant patients consume opioids. Most opioid abusers tamper with tablets to facilitate oral, intranasal, or intravenous administration, whereas compliant patients usually take intact tablets. Pharmaceutical strategies to deter opioid abuse predominantly focus on tablet tampering, incorporating physical barriers (eg, crush resistance) or embedded chemicals that render tampered tablets inert, unusable, or noxious. Deterring tampering and abuse of intact tablets is more challenging. At present, only a few formulations with characteristics designed to oppose tampering for abuse have received approval by the US Food and Drug Administration, and none has been permitted to include claims of abuse deterrence or tamper resistance in their labeling. This review discusses the potential benefits, risks, and limitations associated with available tamper-resistant opioids and those in development. C hronic noncancer pain remains undertreated in the United States despite the availability of effective analgesics, with more than 10% of individuals aged 20 years and older reporting pain lasting more than 1 year. Opioids are standard therapy for postoperative and cancer pain and have gained greater acceptance for moderate to severe chronic noncancer pain in selected patients for whom the benefits of treatment have been determined to outweigh the risks.

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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

Cited by 34 publications

References 31 publications

Opioid Induced Constipation

Opioid Induced Constipation

Opioid formulations with sequestered naltrexone: a perspective review

Strategies to Reduce the Tampering and Subsequent Abuse of Long-acting Opioids: Potential Risks and Benefits of Formulations With Physical or Pharmacologic Deterrents to Tampering

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