FDA takes aim at opioid epidemic | June 19, 2017 Issue - Vol. 95 Issue 25 | Chemical & Engineering News
Volume 95 Issue 25 | p. 8 | News of The Week
Issue Date: June 19, 2017 | Web Date: June 16, 2017

FDA takes aim at opioid epidemic

Agency wants to pull opioid from market because it says the drug’s benefits don’t outweigh its risks
Department: Science & Technology
News Channels: Organic SCENE
Keywords: molecule of the moment, drug safety, opioid epidemic, oxymorphone, FDA, drug formulation

The U.S. Food & Drug Administration has requested that Endo Pharmaceuticals remove its painkiller Opana ER from the market. Opana ER’s active ingredient, oxymorphone, is an opioid similar to morphine but with an added hydroxyl group that makes it 10 times as potent.

The agency says this is the first time it has taken steps to halt sales of an opioid over concerns of public abuse. In 2012, Endo reformulated Opana ER to make it harder for people to crush the drug, and thereby snort it, and to dissolve the drug, and thereby inject it. The firm did so with help from German drugmaker Grünenthal’s Intac technology, which uses a high-molecular-weight polyethylene oxide and proprietary excipients to make it difficult to break the pills into fine particles and to make them gel when dissolved.

Still, people with opioid addiction have figured out ways to inject it, and FDA says illicit use of Opana ER has been associated with an outbreak of HIV and hepatitis C. “We are facing an opioid epidemic—a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said newly appointed FDA Commissioner Scott Gottlieb in a statement. Endo says it’s currently evaluating its “full range” of options.

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Steffen Fritzsche (June 19, 2017 2:15 PM)
Here is Grünenthal’s statement, in response to FDA’s request.

Grünenthal supports our partner Endo Pharmaceuticals, who holds the marketing authorization for OPANA® ER, as it determines the potential options stemming from this FDA decision.
We agree with the U.S. FDA’s assessment that abuse-deterrent formulations (ADFs) are a high public health priority and must be part of a comprehensive approach to address the opioid epidemic in this country. People living in severe pain deserve treatment options that are effective and prevent abuse and misuse. Because every medicine is different and patients respond differently to available medicines, Grünenthal designs abuse-deterrent technologies that are customizable to a variety of active ingredients, dosages, dosage forms, and release profiles.
We are working with the scientific community, medicines makers, and the FDA to continue to advance innovative ADF technologies that deter emerging forms of abuse while helping ensure pain medication is available for patients who use it appropriately, as prescribed by their treating physician.

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