OxyContain Manufacturers to Make Abuse-Resistant Pain Killer

OxyContain Manufacturers to Make Abuse-Resistant Pain Killer

March 17th, 2014 // 12:24 pm @

Soon after FDA announced last week that Zohydro – a painkiller that is supposed to be 10x more potent than Vicodin – is going to be made available in CA this month, the manufacturers of OxyContin stated that they are going to submit their own abuse-resistant painkiller to FDA for approval.

The new drug, which is made by Purdue Pharma, will be more abuse resistant because it cannot be snorted or injected. The pills are made in such a way that they cannot be crushed into powder.

The back lash to the Zohydro announcement has been big. The stock for Zogenix, who makes Zohydro, dropped 20% after the big announcement from FDA. Doctors are likely to be more likely to prescribe a form of hydrocodone that is harder to abuse. FDA could possibly pull Zohydro off the market eventually if it thinks there is a safer alternative out there.

The controversy over Zohydro continued last week as FDA Commissioner Margaret Hamburg testified in front of a Senate Committee. Senator Joe Manchin from WV introduced a bill that would force the agency to pull the drug and to prohibit approving any similar drug that does not have tamper resistant designs that will minimize abuse.

Zohydro is the first one ingredient hydrocodone drug that has ever been approved by FDA for US patients. Each pill, which is extended release, has five times more of the drug than pills that were available before.

Manchin stated that he tried to talk FDA out of approving the drug. Due to what he calls the painkiller’s potential for abuse, Zohydro is a dangerous threat to communities across the country.

Hydrocodone is the most abused prescription drug in the US, says the DEA. The CDC states that hydrocodone and similar opiates accounted for 17,000 deaths in the US in 2010. That is a 400% increase from 1999.

Hamburg noted that acetaminophen, which is a non addictive pain reliever that is often prescribed, has its own safety risks, such as liver toxicity when taken in high dosages.

Some experts note that FDA should have ordered Zohydro to be made in a way that is hard for abusers to crush or chew. Doing this can release a big, heroin like shot of the drug that can be fatal.

She said that tamper resistant technologies are in their early stages. FDA has approved only one drug with those features – the tamper resistant form of Oxycontin.



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