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Friday, April 3, 2015

FDA Issues Guidelines On Abuse-Deterrent Opioids

Part of the problem with prescription opioids is that they can be easily abused. This aspect has lead to an epidemic and an exponential rise in opioid overdose deaths. In the past most drugs that were marketed as having abuse-deterrent properties have simply reinforced the maxim ‘where there is a will, there’s a way.’ People abusing prescription opioids quickly find ways to outsmart tamper resistant drugs.

This week, the U.S. Food and Drug Administration (FDA) issued guidelines for drug manufacturers on developing prescription opioids that are more difficult to abuse, The Wall Street Journal reports. While the FDA acknowledged the pills aren't “abuse-proof,” they would like to encourage the production of pain medications that are more difficult to crush, inject or snort.

“We hope that this guidance is going to provide an incentive for real abuse-deterrent products,” said Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA’s center for drug evaluation. “We hope industry will find that this guidance lays out a road map” for how to make abuse-deterrent drugs that will gain FDA approvals.

The FDA’s move is certainly a step in the right direction; however, not everyone in the field of medicine is thrilled, according to the article.

“It does very little,” said Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. “The ability of so-called abuse-deterrent formulations to have impact on our opioid abuse problems is limited.”

Dr. Kolodny believes that if the FDA were to take larger doses of opioids off the market it may be more effective. He added that if the FDA were to prohibit marketing powerful narcotics for certain conditions it would reduce abuse rates. People with lower-back pain account for about 60% of the people prescribed opioids.

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