The U.S. Food and Drug Administration has issued final guidance for pharmaceutical companies to develop versions of opioid pain-relieving drugs that are less prone to abuse.
The agency stated it was taking a “flexible, adaptive approach” in working with the pharmaceutical industry in its evaluation and labeling of drug-abuse deterrent products.
“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” FDA Commissioner Dr. Margaret Hamburg said in a statement. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”
The FDA's guidance, released Wednesday, offers clarification on the agency's position regarding how testing should be conducted to determine if a painkiller has drug-abuse deterrents.
Testing will include assessing how easily an opioid can be extracted from a painkiller, either by physically crushing a pill or through dissolving them in water or a solution to bypass products that may have extended-release mechanisms meant to slowly distribute the opioid into the taker's system.
Calls for technological improvements on opioid painkillers have grown louder in recent years as the U.S. rate of prescription-drug abuse has increased significantly over the past two decades.
More than 2 million Americans in 2012 were estimated to have a substance abuse disorder related to the use of prescription opioid pain relievers, according to the National Institutes of Health's National Institute on Drug Abuse.
An average of 120 people die in the U.S. each day due to drug overdose, now the leading cause of death through injury, according to the Centers for Disease Control and Prevention.
The final guidance does not cover generic opioid drugs, which the agency stated it would address in future draft guidance.
