Abuse-Deterrent Opioid Formulations #329

U.S. Food and Drug Administration (FDA) News Release: FDA takes important step to increase the development of, and access to, abuse-deterrent opioids. 2016. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm492237.htm (Last accessed August 3, 2016).

Denisco RA , Chandler RK , Compton WM : Addressing the intersecting problems of opioid misuse and chronic pain treatment. Exp Clin Psychopharmacol, 2008; 16:417–428.

Gasior M , Bond M , Malamut R : Routes of abuse of prescription opioid analgesics: A review and assessment of the potential impact of abuse-deterrent formulations. Postgrad Med, 2016; 128:85–96.

Childers JW , King LA , Arnold RM : Chronic pain and risk factors for opioid misuse in a palliative care clinic. Am J Hosp Palliat Care, 2015; 32:654–659.

Koyyalagunta D , Bruera E , Aigner C , et al.: Risk stratification of opioid misuse among patients with cancer pain using the SOAPP-SF. Pain Med, 2013; 14:667–675.

U.S. Food and Drug Administration (FDA): Draft guidance: General principles for evaluating the abuse deterrence of generic solid oral opioid drug products. 2016. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM492172.pdf (Last accessed August 3, 2016).

U.S. Food and Drug Administration (FDA): Opioid medications, abuse-deterrent opioids. 2016. www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm (Last accessed August 3, 2016).

Product Information: OXAYDO(TM) oral tablets, oxycodone HCl oral tablets. Acura Pharmaceuticals, Inc. (per manufacturer), Palatine, IL, 2014. Product Information: OXYCONTIN^® oral extended-release tablets, oxycodone HCl oral extended-release tablets. Purdue Pharma L.P (per FDA), Stamford, CT, 2015.

U.S. Food and Drug Administration (FDA): FDA takes important step to increase the development of, and access to, abuse-deterrent opioids. 2016. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm492237.htm (Last accessed December 12, 2016).

U.S. Food and Drug Administration (FDA): Fact Sheet: FDA opioids action plan. 2016. www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm (Last accessed December 12, 2016).

Product Information: TARGINIQ ER^® oral extended-release tablets, oxycodone HCl oral extended-release tablets. Purdue Pharma L.P (per FDA), Stamford, CT, 2015.

Product Information: EMBEDA^® oral extended-release capsules, morphine sulfate naltrexone HCl oral extended-release capsules. Pfizer Inc (per FDA), New York, NY, 2014.

Product Information: HYSINGLA ER^® oral extended-release tablets, hydrocodone bitartrate oral extended-release tablets. Purdue Pharma L.P. (per FDA), Stamford, CT, 2014.

Product Information: MORPHABOND^® oral extended-release capsules, morphine sulfate oral extended-release capsules. Inspirion Delivery Technologies LLC (per FDA), Valley Cottage, NY, 2015.

Product Information: XTAMPZA ER^® oral extended-release capsules, oxycodone HCl oral extended-release tablets. Patheon Pharmaceuticals (per FDA), Cincinnati, OH, 2016.

Product Information: Troxyca ER^® oral extended-release capsules, oxycodone HCl naltrexone HCl oral extended-release capsules. Pfizer Inc (per FDA), New York, NY, 2016.

Coplan PM , Chilcoat HD , Butler SF , et al.: The effect of an abuse-deterrent opioid formulation on opioid abuse-related outcomes in the post-marketing setting. Clin Pharmacol Ther. 2016; 100:275–286.

Larochelle MR , Zhang F , Ross-Degnan D , Wharam JF : Rates of opioid dispensing and overdose after introduction of abuse-deterrent extended-release oxycodone and withdrawal of propoxyphene. JAMA Intern Med, 2015; 175:978–987.

Keast SL , Owora A , Nesser N , Farmer K : Evaluation of abuse-deterrent or tamper-resistant opioid formulations on overall health care expenditures in a State Medicaid Program. J Manag Care Spec Pharm, 2016; 22:347–356.