Achieving approval for abuse-deterrent opioids in the era of an opioid epidemic

Chris Miller, scientific lead at 3D Communications, provides his perspective on the regulatory challenges facing pharmaceutical companies that are developing opioid products designed to deter abuse in an Expert View piece.

More than 42,000 Americans died from an opioid overdose in 2016. The number of deaths each year from opioids now surpasses the number of Americans who died each year from AIDS at the height of that epidemic in the mid-1990s. While misuse and abuse of prescription opioid medications is a public health crisis, these medicines remain essential for patients suffering from moderate or severe postsurgical or cancer pain.

The US Food and Drug Administration (FDA) has encouraged pharmaceutical companies to develop abuse-deterrent formulations (ADF) of opioids to make them more difficult or less rewarding to abuse. The regulatory hurdle to achieve FDA approval of a new drug application (NDA) for an ADF is high. Companies must submit data from complex in vitro testing and customized clinical trials, and subsequently justify the clinical meaningfulness of the results at an expert advisory committee (ADCOM) meeting. Since 2015, the FDA has followed its advisory committee’s recommendation on whether or not to approve the ADF every time.