FDA Looks Closely at Opioid APIs

FDA Looks Closely at Opioid APIs

August 15th, 2013 // 6:09 pm @

Latest FDA and cGMP Compliance News

Source: Pharmalot

FDA has given close attention to the cGMP quality of active pharmaceutical ingredients, or APIs. Now it is doing some heavy research on the specific APIs that are being used in opioids.

FDA wants more work done at examining the APIs and also excipients, as well as the technology that is used to make opioid pain pharmaceuticals, to see what could make them more resistant to tampering.

An FDA soliticitation that we saw on this stated that the research is to investigate what the effects of physiocochemical properties of both the excipients and the active ingredients, and the drug product composition. Also, the research would look at the technology for drug product manufacturing on the manipulation of the drug for extracting the API for abuse.

This research will be an adjustment to FDA guidance from early 2013 on the formulation and the manufacture of opioid pain drugs that are resistant to tampering. That document laid out what FDA is thinking on studies from drug companies that are taking that route. FDA is under a lot of pressure to lead the way in making opioids harder to abuse.

In its FDA guidance, the agency stated that opioid analgesics are key to pain management, but their abuse is a serious health care problem. CDC reported that opioid abuse has increased 400% among women and 250% among men since 1999.

Last April, FDA banned any generics of the original formulation of Oxycontin, because the abuse dangers outweighed the benefits of a cheap version of the drug. It also provided Oxycontin maker Purdue Pharma with the right to put a claim on its newer version of the drug, which is harder to abuse.

Now, the agency wants to get data on what is working and what is not as far as creating a version of the drug that is hard to abuse. This could help it to better evaluate generics or possibly new drugs that might be approved.


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