Zogenix ($ZGNX) is facing some quick competition for its controversial pain drug Zohydro.
Teva ($TEVA) announced that its abuse-resistant version of extended-release hydrocodone--the opioid CEP-33237--aced a pivotal Phase III. Unsurprisingly, the pain drug beat out a placebo in the chronic back pain study, which sets the stage for a new drug application for later in the year. Purdue Pharma, meanwhile, has already raced to the FDA with its own tamper-resistant version of hydrocodone.
Pfizer, meanwhile, today touted results from three pivotal studies for its pain drug contender, ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules). Investigators touted better efficacy than a placebo for lower back pain with added evidence of its potential for deterring abuse.
The FDA overlooked the opinions of its expert panel when it approved Zogenix's Zohydro recently. Launched in March, the drug is the first all-hydrocodone pain reliever the agency has allowed onto the market. The approval of a drug without abuse deterrence built in, though, sparked an immediate uproar from coast-to-coast, as newspapers and TV news operations of every stripe raised the prospect of another epidemic of abuse similar to the calamity caused by OxyContin.
Massachusetts made an unsuccessful bid to ban Zogenix's opiate drug, citing alarms about its potential for misuse. But the company successfully argued that the state can't trump federal rules on the issue, getting a federal judge to issue a temporary injunction.
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| FDA Commissioner Margaret Hamburg |
The FDA's Margaret Hamburg has staunchly defended the agency's position, saying that doctors and patients need choices like this to manage pain. The agency has signaled its eagerness to approve other, safer drugs that could do what Zohydro does. And it's about to get that chance.
"Healthcare professionals need an array of therapeutic options in order to individualize the care they provide to their patients with chronic pain," said Todd Baumgartner, the regulatory affairs chief and CMO at Purdue Pharma. "If approved by the FDA, we believe this product will be a valuable therapy for use in treating chronic pain that is also expected to deter misuse and abuse by various routes of administration."
- here's the release from Teva
- and the release from Purdue
- here's the release from Pfizer