FDA issues final guidance on abuse-deterrent opioids
- New guidance from the FDA focuses heavily on which studies best demonstrate whether an opioid can be considered abuse deterrent—however, the agency emphasizes that abuse-proof opioids don't exist. There are four categories of study.
- The FDA convened a public meeting on October 30-31, 2014 to discuss the development, assessment and regulation of abuse-deterrent formulations of opioid medications.
- The FDA concedes that the science of abuse-deterrent technology is still evolving.
According to the World Health Organization, approximately two million Americans are addicted to opiates, while the the Institute of Medicine estimates that 100 million Americans suffer from chronic pain. Some of these patients have chronic pain that can only be alleviated with the sort of daily, around-the-clock, long-term opioid treatment that is ripe for abuse. The unfortunate reality is that prescription opioid abuse kills more Americans each year than cocaine and heroin combined.
Pain-management experts advocate for sufficient pain-control measures, but the challenge of opiate addiction and the ability of addicts to crush and snort Rx medications has led to a climate in which patients often have a hard time accessing medicine.
That's where abuse-deterrence comes in. Within the last several months, Biopharma Dive has covered the approval of abuse-deterrent opioids, such as Targiniq ER (naloxone/oxycodone) from Purdue Pharma and Zohydro ER (hydrocodone bitrartate) from Zogenix. All of these were approved under the old draft guidance. Going forward new approvals will be reviewed taking the finalized guidance into consideration.
- FDA FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
- Regulatory Affairs Professionals Society FDA Finalizes Approach to Abuse-Deterrent Opioids