Purdue preps potential Zohydro killer for FDA review after positive PhIII
As the commercial release of Zogenix's hydrocodone bitartrate pain drug Zohydro spawns headlines from coast-to-coast warning of a potential epidemic of abuse similar to what was seen with OxyContin, the rival Purdue Pharma says it has successfully wrapped a Phase III trial of its abuse-resistant competitor. And the data sets the stage for an FDA filing later this year as Zogenix ($ZGNX) labors at its own early-stage efforts at making a pain pill that's harder to abuse.
The FDA triggered a firestorm of controversy recently when officials decided to ignore a lopsided expert panel vote against Zohydro--largely because of its potential for being abused by addicts looking for a quick high by crushing, snorting and injecting the painkillers--and approved the pain drug for marketing. Consumer groups, influential politicians and physicians swiftly moved in on the attack, saying that the FDA had set up another scenario for drug abuse that was likely to be felt in every city and town in the U.S.
"It's the perfect drug of abuse for drug users," one doctor in Orange County warned CBS, as media groups around the country seized on the issue. And there's no sign that the controversy will end anytime soon--unless a competitor drug like this comes along.
Over at Bloomberg, writer Drew Armstrong notes that FDA pain drug czar Bob Rappaport has already said the agency would consider jerking Zohydro from the market if an abuse-resistant version become available.
That would make Purdue very happy.
"We firmly believe that the market must move to all abuse-deterrent formulations," Purdue R&D chief Gary Stiles told Bloomberg. "There's not a technical reason why we and others can't do that." Purdue originally developed and sold Oxy, which started the whole controversy.
Zogenix's investors didn't miss the implications of Purdue's advance today. The biotech's stock, which has been on the rise, is down 17% Wednesday morning.
But before Zogenix's new marketing effort is damaged, Purdue has to win an approval.
According to Stamford, CT-based Purdue, investigators determined that the majority of patients treated with once-daily hydrocodone bitartrate "experienced at least a 30% improvement in pain intensity. Nearly half of patients (48%) achieved a 50% improvement with hydrocodone bitartrate. The most common adverse events (≥5%) reported by patients treated with the once-daily agent were constipation, nausea, vomiting, dizziness and headache, which are typically associated with opioid analgesics."