Team Against Opioid Abuse

Rates of Opioid Dispensing and Overdose After Introduction of Abuse-Deterrent Extended-Release Oxycodone and Withdrawal of Propoxyphene

Opioid dispensing and prescription opioid overdoses decreased substantially after 2 major changes in the pharmaceutical market in late 2010. Pharmaceutical market interventions may have value in combatting the prescription opioid overdose epidemic, but heroin overdose rates continue to increase. Complementary strategies to identify and treat opioid abuse and addiction are urgently needed.

Abuse-Deterrent Opioids — Evaluation and Labeling

This guidance explains FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. The guidance makes recommendations about how those studies should be performed and evaluated and discusses how to describe those studies and their implications in product labeling.

Abuse-Deterrent Opioids: Advances in Technology (Part 1 of a 3-Part Series)

Chronic pain is a serious medical condition that affects more than 100 million American adults, affecting many to the point where they are unable to work, maintain relationships, or even participate in daily tasks. It is one of the most common reasons individuals seek medical care, resulting in up to $635 billion in direct medical costs and lost productivity on an annual basis.

Abuse-Deterrent Opioid Formulations: Promising Technology, Unique Challenges

Prescription pain medications such as opioids offer important treatment options for people with severe pain, often providing relief and allowing some to resume their daily activities. Unfortunately, these drugs can be misused, abused, or diverted to others for illicit use — problems that have become pervasive across the country. Each year approximately 4.5 million Americans use prescription pain medications for nonmedical purposes, 1 contributing to more than 16,000 deaths annually.