New extended release pain medication approved by FDA

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New extended release pain medication approved by FDA

A novel extended release opioid pain medication with abuse deterrent features has been approved by the U.S. Food and Drug Administration (USFDA). This is a long-acting form of morphine for the severe pain management and is enough as a daily, around-the-clock dosage. This opioid treatment was confirmed by Egalet Corporation. This comes as a pill which is very tough to crush or liquefy as these techniques can be used by abusers to speed the release of an opioid into the bloodstream. 

Bob Radie, president and CEO of Egalet said in a news release,"With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools. It has physical and chemical properties expected to make abuse by injection difficult which is important given it is the most common non-oral route of morphine abuse and the most dangerous".

In January  2016, FDA advisory panel recommended in a 18-1 vote that this medication has been approved. It is the 7th opioid with abuse deterrent features approved by the FDA with the other ones being OxyContin, Targiniq, Embeda, Hysingla, Morphabond, and Xtampza. Three dosage strengths have been approved (15 mg, 30 mg and 60 mg). This drug was planned to be available in the first quarter of 2017 according to Egalet and it is now available in market

Being the first commercial product made with Egalet’s Guardian technology, it incorporates the medication into a polymer matrix tablet to make it hard to misuse or abuse. Guardian Technology results in tablets that are extremely hard, very difficult to chew, resistant to particle size reduction, and inhibit/block attempts at chemical extraction of the active pharmaceutical ingredient,” as stated by the company on their website. In addition, the technology results in a viscous hydrogel on contact with liquid, making syringe-ability very difficult. These features are important to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation.

The approval of abuse-deterrent medications is still somewhat disputable. The technology does not completely impede abuse and the drugs are still being misused by addicts as per some medical professionals and anti-opioid activists.


Pain News Network

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FDA approves new long acting painkiller

Therapeutic, FDA, Painkiller, Opioids
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