The drugmaker Zogenix said a harder-to-abuse version of its powerful painkiller Zohydro could be reviewed by regulators this fall and, if approved, might hit the market early next year.
The San Diego company said Wednesday that it recently met with Food and Drug Administration representatives, and it expects to submit an extended release, capsule version of Zohydro to the FDA by October.
The company also is working to develop a tablet version of the drug that maintains the medicine’s extended-release properties even when it is crushed or chewed, which addresses one of the ways opioids are abused orally. The tablet also will have features that address abuse by injection or snorting.
Zogenix Inc. is aiming to apply for approval of this tablet version in the first half of 2016.
Zohydro has been a target of critics since it became the first single-ingredient hydrocodone drug ever approved for U.S. patients last fall. The pill contains up to five times more hydrocodone than Vicodin and sparks worry that it will add to the epidemic of opioid drug abuse that is blamed for thousands of overdose deaths annually.
Earlier this year, Zogenix said it created an oversight board of medical, addiction and law enforcement specialists to spot early signs of misuse using data from sources like prescribing statistics and addiction center reports. The drugmaker also announced that it was selling its migraine therapy business to focus on developing abuse-resistant forms of Zohydro.
Zogenix shares jumped more than 11%, or 22 cents, to $2.21 Wednesday in premarket trading. The stock price had dropped 42% so far this year, as of Tuesday’s market close.
Date: July 2, 2014
Source: Associated Press