|FDA Commissioner Margaret Hamburg|
Ever since the FDA approved Zogenix's ($ZGNX) all-hydrocodone painkiller Zohydro last year, both the agency and the company have faced a storm of criticism. The powerful pill, without tamper-resistant features, was destined to be abused, they claimed.
Zogenix wasted little time responding to the outcry, applying for FDA approval on Wednesday for a new, modified version of the drug--a capsule formulation designed to make it difficult for addicts to abuse it by snorting or injecting it.
Zogenix expects the FDA to hand down a decision in the first quarter of 2015, according to a press release from the company. If that decision is positive, Zogenix plans to transition patients from the currently marketed version of the drug to the abuse-deterrent capsules.
The news comes just one week after 15 anti-addiction advocacy groups sent a letter to the U.S. Department of Health and Human Services demanding that FDA Commissioner Margaret Hamburg be forced to resign over the agency's decision to approve Zohydro. Hamburg had been under fire all year--first from 28 state attorneys general demanding the FDA withdraw the approval, then from U.S. Sen. Joe Manchin (D-WV), who introduced a bill to try to force the FDA to pull the plug on the product.
Hamburg, for her part, has continued to defend Zohydro's approval, insisting that the drug fills an important niche for treating patients with chronic pain. The FDA has approved some pain pills with abuse-deterrent characteristics, though Hamburg has acknowledged that such features do little to discourage the most serious of addicts.
Zogenix, nevertheless, is under extreme pressure from legislators seeking to stem the rise of drug addiction. In the spring, Massachusetts Gov. Deval Patrick tried to ban Zohydro, prompting a lawsuit from Zogenix that the company won. Still, the incident got nationwide attention, providing Zogenix with plenty of negative PR.
Then there's the competitive pressure. Purdue Pharmaceuticals, Teva ($TEVA) and Pfizer ($PFE) are all working on pain pills with abuse-deterrent features.
Zogenix said in its statement that the new version of Zohydro is one element of a "comprehensive approach" the company is taking to try to minimize the abuse of painkillers. "We strongly believe that the first line of defense is educating prescribers, pharmacists and patients about the risks, benefits and appropriate use of opioids," said Stephen Farr, president of Zogenix, in the release, adding that the company had implemented risk-mitigation strategies--some required by the FDA and others voluntary. "We are pleased that the available surveillance data demonstrate that these efforts are working," he said.
-here's Zogenix's release