Clinical Efficacy and Safety of Once-Daily Dosing of a Novel, Prolonged-Release Oral Morphine Tablet Compared With Twice-Daily Dosing of a Standard Controlled-Release Morphine Tablet in Patients With Cancer Pain: A Randomized, Double-Blind, Exploratory Crossover Study

Ridgway, Derry; Sopata, Maciej; Burneckis, Arvydas; Jespersen, Lillian; Andersen, Christine

doi:10.1016/j.jpainsymman.2009.08.013

Cited by 23 publications

(11 citation statements)

References 19 publications

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“…In a 2-week, doubleblind, randomized, exploratory crossover study, once-daily Egalet morphine was as effective as twice-daily CR morphine in adult patients with cancer. 56 Steady-state trough concentrations of the 2 formulations were similar. No end-of-dose failure was reported.…”

Section: Physical Vs Pharmacologic Deterrents To Tamperingmentioning

confidence: 89%

“…Egalet morphine is a once-daily ER morphine formulation in which the opioid is embedded in a watersoluble matrix, keeping the tablet intact until it reaches the gastrointestinal tract. 56 Although susceptible to dissolution by gastrointestinal fluid, the product is resistant to extraction by a variety of solvents, most notably ethanol. In a 2-week, doubleblind, randomized, exploratory crossover study, once-daily Egalet morphine was as effective as twice-daily CR morphine in adult patients with cancer.…”

Section: Physical Vs Pharmacologic Deterrents To Tamperingmentioning

confidence: 99%

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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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Section: Physical Vs Pharmacologic Deterrents To Tamperingmentioning

confidence: 89%

Section: Physical Vs Pharmacologic Deterrents To Tamperingmentioning

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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“…The formulation offers the same effective dosing and has been shown to be safe and effective in treating patients with cancer pain [58]. This technology is also being tested for the prolonged-release of hydrocodone [59].…”

Section: Egalet Morphinementioning

confidence: 99%

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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“…This formulation is designed to conserve the tablet intact until reaching the gastrointestinal tract. Embedding the morphine component in a water-soluble matrix allows for this [52]. As a result, this formulation is impervious to extraction by ethanol and various other solvents [52].…”

Section: Oxycontin Op (Purdue Pharma Lp Stamford Ct Usa)mentioning

confidence: 99%

Abuse-deterrent and tamper-resistant opioids: how valuable are novel formulations in thwarting non-medical use?

Lourenço

Matthews

Jamison

2012

Expert Opinion on Drug Delivery

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Numerous concerns with the integration of these formulations into clinical practice remain, as no product is intended or capable of addressing all types of misuse or abuse. As a result, these formulations should not necessarily be considered preferred agents once available in clinical practice. Moreover, before initiating therapy with abuse-deterrent and tamper-resistant formulations, proper patient assessment to identify risk factors for misuse and abuse should be implemented and optimized. With screening and monitoring in place, it would then be sensible to consider these formulations in patients who appear to be at high risk of misuse, abuse and/or diversion.

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Clinical Efficacy and Safety of Once-Daily Dosing of a Novel, Prolonged-Release Oral Morphine Tablet Compared With Twice-Daily Dosing of a Standard Controlled-Release Morphine Tablet in Patients With Cancer Pain: A Randomized, Double-Blind, Exploratory Crossover Study

Abstract: In this study, dosing with ADPREM at intervals of 24 hours was therapeutically equivalent to CRM dosed at intervals of 12 hours.

Cited by 23 publications

References 19 publications

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

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

The Clinical Applications of Extended-Release Abuse-Deterrent Opioids

Abuse-deterrent and tamper-resistant opioids: how valuable are novel formulations in thwarting non-medical use?

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