Recently in pharmaceutical news, the U.S. Food and Drug Administration (FDA) issued a final guidance to assist in the development of opioid drugs with properties that make the drugs, such as oxycodone, less likely to be abused, according to an article at Packaging World.
Drugs containing opioids, such as oxycodone, Percocet, codeine, Vicodin, and hydrocodone are prescribed for patients who suffer from pain that cannot be managed by acetaminophen, ibuprofen, and other over-the-counter drugs. However, these drugs are widely abused because of their euphoric properties. Opioids carry a substantial risk of abuse, addiction, and death. Because of this, the FDA has encouraged manufacturers of these drugs to develop formulations of these drugs that provide substantial benefit to patients who suffer pain, but deter the abuse often accomplished via injecting or snorting for a more intense high. The FDA has compiled a document titled “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” which clarifies the agency’s current thinking regarding the studies that should be conducted to show that a given formulation of an opioid drug has abuse-deterrent properties.
According to FDA Commissioner Margaret A. Hamburg, M.D., the science of medications that are abuse-deterrent is rapidly evolving. Hamburg claims that the FDA is eager to engage with manufacturers to assist in making opioid medications available to patients who really need them in the management of pain. She went on to say that, “We feel this is a key part of combating opioid abuse, and must work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”
The final guidance by the FDA doesn’t address opioid products that are generic, however the agency does understand how critical it is that patients who do not have financial means have generic options available to them. The FDA continues to work on providing industry with guidance in the area of generic opioid drugs, and is dedicated to working with drug manufacturers in an effort to support advancement of medications that, while providing pain relief to patients who really need them, also deter from the potential of abuse for these medications. According to the article, the Food and Drug Administration intends to take an adaptive, flexible approach to the evaluation and labeling of products that have the potential for abuse.
At REA JET, we know that many prescription opioid drugs are abused and addictive. While the improved formulations designed to deter abuse of opioid drugs cannot completely prevent abuse or addiction to the drugs, the hope is that it will play a vital role in reducing the abuse and misuse of opioids.
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