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news.The US Food and Drug Administration (FDA) has approved Purdue Pharma's Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment.
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Hysingla ER is a once-daily, single-entity medication formulated using the company’s extended-release solid oral platform, RESISTEC, which uses a combination of polymer and processing that confers tablet hardness and imparts viscosity when dissolved in aqueous solutions.
It is the first and only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection.
According to the FDA, the hydrocodone has abuse-deterrent properties that are expected to deter misuse and abuse through chewing, snorting and injection.
The tablet is difficult to crush, break or dissolve, while it also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection.
In addition, Hysingla ER does not carry the serious liver toxicity risks related with hydrocodone combination products containing acetaminophen.
Albany Medical College professor of Neurology and Albany Medical Center director of the Comprehensive Pain Center Charles Argoff said: "The burden of chronic pain and the abuse of prescription medications are both pressing societal problems.
"Opioids are an essential tool in our arsenal of medical treatments options, so greater availability and use of opioid analgesics with abuse-deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications.
"Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis."
The company intends to introduce Hysingla ER in the US in early 2015 in dosage strengths of 20mg, 30mg, 40mg, 60mg, 80mg, 100mg and 120mg to be taken once every 24 hours.