Zogenix knows it needs to step on the gas. If the company doesn't develop an abuse-resistant version of its controversial-and-powerful painkiller Zohydro--and quickly--another drugmaker will speed past. And that could put Zohydro out of the race completely.
Zogenix recently met with FDA officials to hash out a timeline for new versions of Zohydro, the first all-hydrocodone painkiller. It's now planning to submit a version of the extended-release drug in capsule form in October, aiming to launch early next year. That formulation would be more difficult to abuse by injection or snorting, the company said in a statement. And it's aiming for the first half of 2016 for a filing on a hard-to-abuse tablet.
It's none too soon. Purdue Pharmaceuticals, inventor of the notorious painkiller blockbuster OxyContin, is already hard at work on a hydrocodone-only, abuse-resistant pill. Given that it has already introduced an abuse-deterrent version of OxyContin, Purdue obviously has the technology to pull off a similarly formulated hydrocodone pill.
Meanwhile, Teva has racked up enough Phase III data on an abuse-resistant version of extended-release hydrocodone for an FDA filing later this year. And Pfizer has its own high-powered painkiller on the way, with tamper-resistant features already built in. The drug giant recently touted results of three key studies on that drug, ALO-02.
Aside from the competitive considerations, there's the public relations factor to consider. Since Zohydro won FDA approval last year, Zogenix has been under fire for marketing such a powerful painkiller without tamper-resistant features. After all, the U.S. has experienced an epidemic-level addiction problem, and law enforcement officials across the country have been scrambling to fight back. Massachusetts Gov. Deval Patrick even tried to ban the drug from his state, citing its potential for abuse. And the FDA hasn't gone unscathed, either; lawmakers and activists panned the agency's approval and lobbied for FDA to revoke it.
The FDA has staunchly defended its decision, saying there are plenty of legitimate patients who need a drug like Zohydro to deal with excruciating pain. Zogenix set up an oversight board to help track sale stats to identify any misuse early on.
But the FDA has also said that it's eager to approve abuse-deterrent alternatives to Zohydro if they became available. In fact, the agency's pain drug chief Bob Rappaport has said that FDA would consider pulling Zohydro from the market if those alternatives win approval.
- see the release from Zogenix