Zogenix, the San Diego drug company preparing to market the potent painkiller Zohydro in March, relies on WCG for PR counsel.
The Food and Drug Administration approved Zohydro in October, but some consumer and healthcare critics are mounting a pushback over fears of abuse and overdose.
The drug is intended for treating chronic pain on a daily, extended basis.
An umbrella group of doctors, consumer advocates and addictions groups, among others, is urging the FDA to reverse course as they fear the opioid drug will exacerbate what they see as over-prescribing and abuse of painkillers. They warn Zohdryo could "be the next Oxycontin."
Zogenix, which has beefed up its sales and marketing staff ahead of the launch, says that its drug does not contain acetaminophen, which causes liver failure in high doses and is present in abused drugs like Vicodin and Lortrab. In addition to plans for warning labels on prescriptions, the company has set up an "external safe-use board" to ensure Zogenix will receive timely, independent and thorough feedback and recommendations" on the use of Zohydro after launch next month. That group includes members from the medical, law enforcement, and addiction specialty sectors.
The advocacy group, dubbed FED UP!, noted the highest dose of Zohydro will contain as much as 10 times the hydrocodone in commonly abused painkillers. "A single capsule could be fatal if swallowed by a child," the group said in a petition to the FDA.
"I'm not optimistic about our chances of keeping Zohydro off the market," Andrew Kolodny, chief medical officer of Phoenix House and member of the coalition, wrote in the Huffington Post Feb. 26. "But with a Senate investigation and a large turnout at the September FED UP! rally, we may be able to keep the next Zohydro-like opioid off the market
WCG started working with eight-year-old Zogenix in 2012.