Maker of Zohydro ER Submits Resistant-Proof Drug to FDA

Maker of Zohydro ER Submits Resistant-Proof Drug to FDA

By John Lavitt 10/07/14

Under the microscope, pharmaceutical company Zogenix is trying to stave off controversy over its highly-addictive new painkiller.

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Ever since the scandal of Zohydrogate, when the FDA overturned its own expert panel’s negative recommendation and approved the dangerous opioid painkiller Zohydro ER, the small pharmaceutical company Zogenix has been in the spotlight.

In an attempt to stem the tide of potential controversy as the drugs gains a foothold in the marketplace, Zogenix submitted an application to the Food and Drug Administration for a new version of the drug that it contends will be less susceptible to abuse.

For close to a year, Zogenix has been under siege as health advocates underscored how Zohydro ER was ripe for abuse. By offering a high dose of the pure opioid hydrocodone with the power to deliver an immediate heroin-like high when misused, Zogenix was accused of proffering a drug that could be described as an addict’s wet dream. Zohydro ER’s critics were shocked no safety deterrents were included in the original formulation.

Zogenix has claimed that the new Zohydro ER formulation, "contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection" and snorting it through the nose. Those details include a jelly-like substance within the capsules.  When asked for more details, the company declined to provide them, citing intellectual property rights and the control of proprietary information.

Still, Stephen Farr, Ph.D., president of Zogenix, stated with pride in a recent press release:

"The new technology being added to Zohydro ER represents a meaningful advancement because it incorporates properties designed to deter abuse yet maintain the efficacy of the medication, a central consideration throughout the product's development," Farr said. "We have implemented the FDA's Risk Evaluation and Mitigation Strategy program for extended-release/long-acting opioids and are continuing with our voluntary initiatives to support the responsible commercialization of Zohydro ER. We are pleased that the available surveillance data demonstrate that these efforts are working."

Failing to satisfy many of their critics, some addiction doctors have expressed concern that opioid abusers will be able to get high by breaking open and swallowing the jelly-like contents of multiple capsules. Several doctors and anti-addiction activists have even gone so far as to call for the resignation of FDA Commissioner Margaret A. Hamburg over the painkiller issue, including Zohydro.

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Growing up in Manhattan as a stutterer, John Lavitt discovered that writing was the best way to express himself when the words would not come. After graduating with honors from Brown University, he lived on the Greek island of Patmos, studying with his mentor, the late American poet Robert Lax. As a writer, John’s published work includes three articles in Chicken Soup For The Soul volumes and poems in multiple poetry journals and compilations. Active in recovery, John has been the Treatment Professional News Editor for The Fix. Since 2015, he has published over 500 articles on the addiction and recovery news website. Today, he lives in Los Angeles with his beautiful wife, trying his best to be happy and creative. Find John on Facebook, Twitter, and LinkedIn.

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