Development and impact of prescription opioid abuse deterrent formulation technologies

Alexander, Louis; Mannion, Richard O.; Weingarten, Brianne; Fanelli, Richard J.; Stiles, Gary L.

doi:10.1016/j.drugalcdep.2014.02.006

Cited by 60 publications

(42 citation statements)

References 32 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Some other currently available opioid analgesics have also been reported to have potential abuse-deterrent properties; however, these have not yet met the necessary regulatory requirements for an ADF label. [94][95][96][97][98][99] A growing body of evidence suggests that introduction of the abuse-deterrent formulation of oxycodone has been associated with decreased rates of abuse and diversion of this opioid analgesic in the USA. [101,[110][111][112][113][114][115][116][117][118][119].…”

Section: Differences In Routes Of Abuse Between Populationsmentioning

confidence: 99%

“…[94][95][96][97][98][99][100] Available abuse-deterrent formulations aim to hinder extraction of the active ingredient, limit its bioavailability, prevent administration through alternative routes and/or make abuse of the manipulated product much less attractive, less rewarding or even aversive. Possible approaches to abuse deterrence include physical and chemical barriers to prevent manipulation of the formulation and extraction of the active ingredient, combination with an antagonist, aversion technologies, use of new molecular entities or prodrugs, and novel delivery systems.…”

Section: Differences In Routes Of Abuse Between Populationsmentioning

confidence: 99%

See 1 more Smart Citation

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Gąsior

Bond

Malamut

2015

Postgraduate Medicine

View full text Add to dashboard Cite

Prescription opioid analgesics are an important treatment option for patients with chronic pain; however, misuse, abuse and diversion of these medications are a major global public health concern. Prescription opioid analgesics can be abused via intended and non-intended routes of administration, both intact or after manipulation of the original formulation to alter the drug-delivery characteristics. Available data indicate that ingestion (with or without manipulation of the prescribed formulation) is the most prevalent route of abuse, followed by inhalation (snorting, smoking and vaping) and injection. However, reported routes of abuse vary considerably between different formulations. A number of factors have been identified that appear to be associated with non-oral routes of abuse, including a longer duration of abuse, younger age, male sex and a rural or socially deprived location. The development of abuse-deterrent formulations of prescription opioid analgesics is an important step toward reducing abuse of these medications. Available abuse-deterrent formulations aim to hinder extraction of the active ingredient, prevent administration through alternative routes and/or make abuse of the manipulated product less attractive, less rewarding or even aversive. There are currently five opioid analgesics with a Food and Drug Administration abuse-deterrent label, and a number of other products are under review. A growing body of evidence suggests that introduction of abuse-deterrent opioid analgesics in the USA has been associated with decreased rates of abuse of these formulations. The availability of abuse-deterrent formulations therefore appears to represent an important step toward curbing the epidemic of abuse of prescription opioid analgesics, while ensuring the availability of effective pain medications for patients with legitimate medical need.

show abstract

Section: Differences In Routes Of Abuse Between Populationsmentioning

confidence: 99%

Section: Differences In Routes Of Abuse Between Populationsmentioning

confidence: 99%

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Gąsior

Bond

Malamut

2015

Postgraduate Medicine

View full text Add to dashboard Cite

show abstract

“…Reformulated ER oxymorphone HCl (reformulated ER oxymorphone) was ''developed to incorporate technology designed to render the tablet highly resistant to crushing without affecting its extended-release properties'', but the FDA determined in May 2013 that the post-marketing investigations supporting an abuse-deterrent claim were inconclusive 10 . The FDA determined that ''[w]hile there is an increased ability of the reformulated version of [ER oxymorphone] to resist crushing relative to the original formulation, study data show that the reformulated version's extended-release features can be compromised when subjected to other forms of manipulation '' 11 .…”

Section: Introductionmentioning

confidence: 99%

Use of prescription opioids with abuse-deterrent technology to address opioid abuse

Michna

Kirson

Shei

et al. 2014

Current Medical Research and Opinion

View full text Add to dashboard Cite

Objective:The development of new formulations of extended-release (ER) opioids with abuse-deterrent technology attempts to deter prescription opioid abuse while maintaining appropriate access to care for pain patients. This study examined the degree to which some patients may avoid switching to reformulated ER opioids with abuse-deterrent technology and the extent to which those patients are more likely to be abusers.

show abstract

“…This prevents intravenous use and causes irritation of the nasal passage, making the preparation unattractive for abuse. Aversion technology is also seen with ADF technology involving the addition of niacin, which by means of its toxic effects such as itching, nausea, diarrhea, and cramps makes the preparation unpleasant for abuse intravenously and intranasally [22]. However, the niacin/oxycodone product is no longer in development.…”

Section: Aversionmentioning

confidence: 97%

The Clinical Applications of Extended-Release Abuse-Deterrent Opioids

Vadivelu¹,

Schermer²,

Kodumudi³

et al. 2016

CNS Drugs

View full text Add to dashboard Cite

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.

show abstract

Development and impact of prescription opioid abuse deterrent formulation technologies

Cited by 60 publications

References 32 publications

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Use of prescription opioids with abuse-deterrent technology to address opioid abuse

The Clinical Applications of Extended-Release Abuse-Deterrent Opioids

Contact Info

Product

Resources

About