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FDA Issues Draft Guidance Regarding Abuse-Deterrent Opioids

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Prescription painkiller abuse is a problem that’s rapidly escalated in recent years, overwhelming law enforcement agencies and treatment centers across the country. Attempts in the past by manufacturers to make formulations abuse proof have failed and one federal agency would like to see that change.
The U.S. Food And Drug Administration has issued a draft guidance document to help the pharmaceutical industry come up with new formulas of opioids that are resistant to abuse.

Medications Once Thought To Be Abuse Proof Have Proven Otherwise

A drug such as OxyContin, a highly potent narcotic, was once thought to be abuse proof because of its time-release formula. The idea was that the main ingredient, oxycodone, would be released over 24 hours so patients wouldn’t absorb the entire drug at once.
But those who abuse such medications quickly realized they could access the full strength of OxyContin by disabling the time-release mechanism. Crushing or chewing the pill allows for rapid absorption of oxycodone. When a potent medication floods the system in this way, overdose and death can occur.
And that’s pretty much what’s been happening with OxyContin ever since. When it was first developed in 1996, people quickly caught on to methods of abuse. Crushing the pill made it easy for folks to snort or mix the OxyContin with liquid for injection. A few years ago, OxyContin was reformulated to include a crush-proof capsule. Abusers either switched to other pharmaceutical painkillers or to heroin, a cheaper and easier-to-find alternative.
In addition, Suboxone, which contains buprenorphine, was believed to be resistant to abuse when it was approved by the FDA for take home use in 2002. The drug, prescribed to control opiate withdrawal associated with addiction, is now thriving on the black market because pills can be crushed and injected.

The FDA Says Recommended Changes Are A ‘High Public Health Priority’

An FDA news release quotes FDA Commissioner Margaret A. Hamburg, MD, as saying, “The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation.”
The FDA says it will continue to encourage manufacturers to develop abuse deterrent formulas and believes this will help to reduce prescription painkiller abuse. The agency said it also remains committed to patients in pain who rely on these medications for quality of life.
The agency will accept public comments about the draft guidance and encourages further research to advance technology related to abuse-deterrent medications. A public meeting to hear feedback on the guidance will also be scheduled. The FDA describes a draft guidance as reflective of the agency’s current thinking on the matter and should be viewed as recommendations. It says this particular guidance “considers the development of these products a high public health priority.”

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