FDA Commissioner Defends New Pain Drug

FDA Commissioner Defends New Pain Drug

March 14th, 2014 // 2:21 pm @

FDA Commissioner Margaret Hamburg this week defended FDA’s approval of Zohydro, which is a powerful opioid that is made by Zogenix. She noted that it offers a unique chance to treat pain, even with serious concerns about abuse.

FDA’s approval of this new drug has drawn a lot of flak, including from the attorneys general of nearly 30 states, and also many groups that represent doctors and addiction treatment experts. They are worried that Zohydro is going to set off a chain of addiction problems that will be similar to the original OxyContin.

The critics of the new drug are petitioning FDA to pull the drug’s approval for marketing.

Hamburg testified this week at a Senate hearing, stating that Zohydro is powerful, but if it is used right, it will serve a very important and unique niche, regarding pain medication. She also said that it meets tough standards for safety and efficacy.

Her remarks to the Senate Health, Education, Labor and Pensions Committee are coming a week after Zogenix announced that the new drug will be available at some pharmacies soon. The drug was approved in October.

In its approval of the drug, FDA decided to overrule its panel of advisors, who recommended to not approve the drug. They were concerned about the potential for abuse.

Hamburg said that when it approved the drug, it recognized its addiction potential and understood the broader problem of opioid medication abuse in the US.

A recent study of government statistics determined that more than 12 million people have abused prescription opioids at least one time in a year to get high.

Senators at the hearing also voiced concerns about abuse. They noted that Zohydro is not made in a way to avoid the ability to crush or chew the pills to get a high.

Senator Joe Manchin from WV said that his state has been hit hard by this type of drug abuse, and he called on the HHS to overturn the approval.

Hamburg argued that unlike other hydrocodone drugs, Zohydro does not have any acetaminophen, which can cause liver problems. She also stated that how doctors prescribe the drugs play a rule in how the drugs are abused.

Abuse of Oxycontin was so popular that Purdue Pharma changed the formula for the drug in 2010 so the drug can’t be easily snorted or injected. Purdue stated this week that it is going to go ahead with a rival drug similar to Zohydro that will not be easy to abuse. Zogenix also is working on another type of Zohydro that will be harder to abuse too.

Hamburg noted that she wants to have abuse deterrent formulations for all of these drugs, but the technology is still developing.


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