Current and future development of extended-release, abuse-deterrent opioid formulations in the United States
Autor: | Lynn R. Webster, Edward J. Cone, G. Niebler, John D. Markman |
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Rok vydání: | 2016 |
Předmět: |
medicine.medical_specialty
Prescription Drugs Chemistry Pharmaceutical Poison control Guidelines as Topic Abuse deterrent Suicide prevention Occupational safety and health 03 medical and health sciences 0302 clinical medicine 030202 anesthesiology Injury prevention medicine Humans Psychiatry United States Food and Drug Administration business.industry Opioid-Related Disorders Human factors and ergonomics General Medicine United States Analgesics Opioid Opioid Delayed-Action Preparations Chronic Pain business 030217 neurology & neurosurgery medicine.drug |
Zdroj: | Postgraduate Medicine. 129:102-110 |
ISSN: | 1941-9260 0032-5481 |
DOI: | 10.1080/00325481.2017.1268902 |
Popis: | Prescription opioid misuse and abuse in the United States (US) is epidemic and is a major burden on health-care resources and costs to society. The need to significantly reduce the risks of prescription opioid misuse and abuse must be balanced with the important needs of patients with chronic pain who may benefit from treatment with opioids. The use of abuse-deterrent formulations (ADFs) of prescription opioids is one approach that could reduce the risk of prescription opioid abuse and misuse while maintaining access to opioids. ADF opioids have properties that make their abuse more difficult, less attractive, or less rewarding. In 2015, the US Food and Drug Administration issued final guidance to industry for the development of ADF opioids that recommended specific studies be conducted to demonstrate the abuse-deterrent properties of new opioid formulations. The technologies and the preclinical and clinical development of ADF opioids are rapidly evolving. This review provides an overview of the required testing for product labeling that includes language about the abuse-deterrent features of an ADF opioid. The objective of this review is to inform and help health-care providers understand the unique development of extended-release ADF opioids and their place in the treatment of patients with pain. |
Databáze: | OpenAIRE |
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