FDA Issues Guidance Outlines for Generic Opioids
FDA Issues Guidance Outline for Generic Opioids

The Food and Drug Administration (FDA) has formulated an outline for a guidance to offer support to pharmaceutical industry in its efforts to develop generic variants of opioid drugs that have been approved by it.

The generic variants will be developed using abuse-deterrent formulations (ADF). However, the FDA has revealed that generic ADF opioids will also be equally abuse-deterrent as the brand-name drug. This guidance is one of the several measures being taken by the FDA under an action plan for the re-evaluation of its advancement towards opioid drugs.

The purpose of the FDA’s plan is to concentrate on issuing policies that can be instrumental in alleviating the opioid drug outbreak and also make sure that the patients suffering from excessive pain have accessibility to drugs providing effective relief. According to the FDA Commissioner Robert Califf, MD., generic opioids will serve as a suitable and economical substitute for patients going through considerable amount of pain and depend on the healthcare system to offer them a solution.

“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,” said Califf. The efforts being made by the industry towards the development of painkillers that cannot be abused easily are being supported by the FDA.

Some particular type of abuses, including crushing a medicine for snorting purpose or dissolving the tablet for injecting purpose, become additionally tough or less pleasurable with abuse-deterrent properties. The FDA clarified that it does not mean that opioid drugs with ADF cannot be abused or are capable of avoiding addiction, overdose or death. Till date, no opioid medication has been approved by FDA that is likely to discourage its abuse in case it is consumed as a whole.




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