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FDA introduces draft plan for abuse-deterrent generic opioids
In its second move in a week aimed at beefing up regulations concerning the nation’s opioid addiction epidemic, the Food and Drug Administration (FDA) has introduced guidelines for the development of abuse-deterrent formulations for all approved generic oral prescription opioids.
Earlier in the week, the agency announced it would call for “black-box” label warnings to all immediate-release (IR) opioid painkillers, which include roughly 175 branded and generic drugs. Similar warnings were added to the labels of extended-release (ER) prescription opioids three years ago.
The FDA said the plan supports the industry’s development of abuse-deterrent formulations (ADF) for generic versions of approved opioids while ensuring that generic ADF opioids are “no less abuse-deterrent than the brand-name drug.”
The plan part of recent changes in FDAS policies aimed at reversing the opioid addiction epidemic “while still providing patients in pain access to effective relief.”
“For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” said FDA Commissioner Robert Califf, MD. “We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.”
The FDA explained that abuse-deterrent properties make certain types of abuse more difficult, particularly crushing a tablet in order to snort it or dissolving and injecting it.
“It does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose or death,” the FDA said. “There are no FDA-approved ‘abuse-deterrence’ opioid products that provide protection against simply swallowing the whole pill.”
There are currently five approved ADF products on the market – OxyContin, Targiniq and Hysingla (Purdue Pharma), Embeda (Pfizer) and Morphabond (Inspirion Delivery Technologies).
Two other opioids, Zohydro (Pernix, formerly Zogenix) and Xtampza (Collegium Pharmaceutical) were not granted approval for abuse-deterrence labeling, although both companies issued press releases promoting the “abuse-deterrent properties” of their drugs.
The FDA said it is still evaluating the effectiveness of currently approved ADF formulations, and that the makers are legally required to conduct long-term post-marketing epidemiological studies to assess the effectiveness of their ADF in reducing abuse in practice.
The FDA said it recognizes that ADFs are not “failsafe” and that more data is needed. But ADF opioids do deter abuse compared to non-ADFs, according to existing data.
“Given the lower cost, on average, of generic products, encouraging access to generic forms of ADF opioids is an important step toward balancing the need to reduce opioid abuse with helping to ensure access to appropriate treatment for patients in pain,” the FDA concluded.
The FDA will hold a public meeting later in the year to get additional input from experts and the public before issuing its final guidelines on the subject.
Here at Novus, we support all efforts to reduced drug abuse and addiction. If you or someone you care about has a problem with drugs or alcohol, don’t hesitate to call. We’re always here to help.
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