New Abuse-Deterrent Narcotic Painkiller Approved by FDA

Pills 1A long-acting narcotic painkiller designed to deter abuse has been approved by the Food and Drug Administration (FDA).

The drug, Hysingla ER, is taken once a day. It is meant to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.

The FDA said Hysingla should reduce, but not necessarily prevent, abuse through snorting or injecting, according to Reuters. Hysingla is difficult to crush, the article notes. If it is cut into small pieces and dissolves, it turns gooey.

The drug is made by Purdue Pharma, which also makes OxyContin. The original version of OxyContin was widely abused and was withdrawn from the market. The current version has abuse-deterrent properties.

Hysingla is a "pure" hydrocodone drug, unlike Vicodin, which contains a combination of short-acting hydrocodone and acetaminophen. The FDA has already approved another extended-release pure hydrocodone drug, Zohydro, which is designed to be released over time. Zohydro is not available in an abuse-deterrent form, and can be crushed and snorted by people seeking a strong, quick high. The FDA's decision to approve Zohydro has been criticized by some legislators and public health groups, who say the drug could increase prescription painkiller abuse.

Earlier this year, the FDA approved Targiniq ER, a painkiller that combines oxycodone and naloxone. The naloxone blocks the euphoric effects of oxycodone, making it less appealing to abuse. Targiniq ER, also made by Purdue Pharma, can be crushed and then snorted or injected. If the pills are crushed, the naloxone becomes active.

The FDA recently approved new labeling for the opioid painkiller Embeda that states the drug has abuse-deterrent features. The label will indicate Embeda has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted. The drug can still be misused if it is swallowed intact. Embeda contains morphine and naltrexone, and comes in extended-release capsules.

 

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Monday, 10 December 2018
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