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FDA to Determine if Oxymorphone, Produced by KVK Tech in Newtown, is More Likely to Be Abused Than Other Opioids

FDA to Determine if Oxymorphone, Produced by KVK Tech in Newtown, is More Likely to Be Abused Than Other Opioids | Newtown News of Interest | Scoop.it

[Oxymorphone is KVK Tech's a best-selling generic drug. If it is piulled from the market, it may spell trouble for the company and its employees.]


Collegium, which makes abuse-deterrent opioids, convinced top health insurers to cover only its product Xtampza — and not Purdue's infamous OxyContin.


Collegium also stands to benefit from FDA actions cracking down on certain opioids. 


 Over the summer, Endo International agreed to comply with the FDA’s request that it pull from the market long-acting Opana, the painkiller blamed for prompting an HIV outbreak in rural Indiana in 2015 when people addicted to opioids began injecting the drug. Since then, 7 percent of patients forced to find a replacement have switched over to Xtampza, according to Collegium. 


 And there may be more to come: Earlier this month, FDA Commissioner Scott Gottlieb announced that the agency is conducting a study of long-acting generic products containing oxymorphone, the same active ingredient that was in long-acting Opana. 


Gottlieb said (http://bit.ly/2mSWr3c): "FDA previously commissioned a study to formally evaluate whether oxymorphone, an active ingredient in certain opioid drugs, has qualities that make it more likely to be abused than other Schedule II opioids, including through illicit routes of administration such as snorting and injection. I’m announcing that study for the first time. If the scientific results of this study demonstrate that this ingredient has qualities that make it more likely to be abused, FDA would consider taking regulatory actions that could limit patient exposure to oxymorphone."

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Newtown News of Interest
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