Will Zogenix Inc (NASDAQ:ZGNX)’s Zohydro lead to addiction?

Posted by Lynn Eisler October 3, 2013 0 Comment 1723 views

On Tuesday, Zogenix, Inc (NASDAQ:ZGNX) said that the United States FDA has delayed its response to the company’s Zohydro application. This ruling had already been put on the back-burner for several months now and this has now been delayed further.

Positive signs

However, the company has announced some developments that are more positive. They announced that the Food Drug Administration have not found anything lacking in its marketing application for the drug and that they have also finalized the agreement about the drug’s safety-label. Another development is that they have agreed upon the study that the company will be required to conduct if Zogenix receives their approval.

In addition, Zogenix, Inc (NASDAQ:ZGNX) said that the DEA has said that the drug will receive Schedule II drug classification. What this indicates is that they believe that the drug has a high-potential for addiction and abuse. The company said that drugs like these generally receive a Schedule III classification which means that their potential for dependence is lower.

The specialized medication

Zohydro is a longer acting variant of hydrocodone, the painkiller. If the FDA gives its nod for the drug it will be the United States’ very first pure hydrocodone-drug. The existing medications are a combination of hydrocodone and other low-grade pain killers like acetaminophen.

In 2012 December, the Food Drug Administration’s advisory panel had voted 11:2 against Zohydro. They had raised concerns about the fact that people who are addicted to painkillers would end up abusing it. This drug belongs to the opiate family of drugs and includes oxycodone, morphine, codeine and methadone.

Wednesday’s trading session

In Wednesday’s trading, Zogenix, Inc (NASDAQ:ZGNX) rose by 14.87%. The shares opened at a price of $2.19, climbed to an intraday high of $2.52 and dipped to a close of $2.24. Approximately 5.40 million shares were traded on Wednesday while an average volume of 0.551 million shares were traded over a 30 day period.

About Lynn Eisler

Lynn Eisler is a national news reporter focusing on economic issues, data analysis and the financial health of state and local governments. Lynn has been honored with the H.L. Mencken Award for Investigative Reporting, the Champion of Justice Award for reporting on the drug war, and the John Hancock Award for business reporting. Lynn was also a Knight Medical School Fellow at the University of Michigan.

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