Sponsored adThis sponsor paid to have this advertisement placed in this section.
Maker of Zohydro ER Submits Resistant-Proof Drug to FDA

Sponsored adThis sponsor paid to have this advertisement placed in this section.
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.
Sponsored adThis sponsor paid to have this advertisement placed in this section.