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The FDA has approved a short-acting opioid painkiller with abuse-deterrent properties, the drugmaker Pfizer announced Monday.Oxecta, a new formulation of oxycodone, had previously been under development as Acurox, which included niacin to deter oral abuse. That version received aÊthumbs downfrom an FDA advisory panel in 2009.The new drug uses ÒAversionÓ technology, licensed from Acura Pharmaceuticals Ñ which is described as a Òunique composition of commonly used pharmaceutical ingredientsÓ Ñ to stop potential abusers from crushing, chewing, snorting, or injecting the opioid. It does not deter oral abuse.But Pfizer noted in a statement that the potential to abuse the drug via these routes still exists and Òthere is no evidence that Oxecta has a reduced abuse liability compared to immediate-release oxycodone.Ó

In an earlier interview, Gail Cawkwell, MD, vice president of medical affairs at Pfizer, toldMedPage Today that the technology causes the drug to break down into crumbled chunks instead of powder if crushed, and turns it ÒsudsyÓ if it is mixed with liquid and drawn into a syringe.

Oxecta is indicated for acute and chronic moderate-to-severe pain and is contraindicated in patients with respiratory depression, paralytic ileus, bronchial asthma or hypercarbia, and in those with a hypersensitivity to the opioid.

Among the most common adverse reactions are nausea, constipation, vomiting, headache, itchiness, trouble sleeping, and dizziness, according to Pfizer.

The new formulation joins aÊhandful of other abuse-deterrent opioids that are on the market or in development. Purdue Pharmaceuticals, maker of long-acting oxycodone (OxyContin), had a tamper-proof version of its drugÊapproved last year.

Making drugs harder to abuse has been one key strategy for some companies in an attempt to control what the government has deemed anÊepidemic of prescription painkiller abuse.

Pfizer acquired Oxecta when it merged with King Pharmaceuticals last year, along with an abuse-deterrent formulation of long-acting oxycodone (Remoxy) which is up for FDA approval on June 23.


By Kristina Fiore, Staff Writer, MedPage Today



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