FDA Approves Painkiller Hysingla ER
November 20, 2014 - The U.S. Food and Drug Administration (FDA) has approved hydrocodone bitartrate (Hysingla ER), a long-acting narcotic painkiller with abuse-resistant properties made by Purdue Pharma L.P. The FDA approved the once-daily drug, with the expectation that it will reduce, though not necessarily prevent, abuse through snorting or injecting. It is the second extended-release, single-entity hydrocodone drug approved by the FDA. The first was Zohydro ER (Zogenix Inc.), approved last year.
Other hydrocodone drugs, such as Vicodin, combine short-acting hydrocodone with acetaminophen or other painkillers. The approval comes at a time of escalating prescription drug abuse, which carries with it hefty costs. Of the 22,114 drug-overdose deaths in 2012, 72% involved opioid analgesics such as hydrocodone, according to the Centers for Disease Control and Prevention.
The FDA's approval of Zohydro, against the advice of its own advisory committee, prompted criticism that the drug would be conducive to prescription painkiller abuse because it is not available in abuse-resistant form; thus, it can be crushed, snorted and injected. Hysingla ER is harder than most pills, making it difficult to crush. If someone tries to cut it into small pieces and dissolve it, the result is a sticky substance. The medication is expected in early 2015.
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