The FDA has approved Zogenix's ($ZGNX) pain med Zohydro ER, sending its shares soaring on the sudden reversal of fortunes for a pure hydrocodone drug that had been rejected by an expert panel in a lopsided vote late last year. And some of the top experts in the field followed up with some harsh criticism for the agency, saying that they are setting up a "disaster in the making."
The expert panel had wanted to put the brakes on the drug while the agency studied ways to curb opioid abuse. But the agency went ahead with a green light for commercialization, restricting its use to patients who can't be helped by other available pain medications and applying new labeling guidelines that will clearly lay out the risks involved in taking the therapy. And the agency is requiring postmarketing studies to examine the potential for misuse and abuse of the therapy, a Schedule II controlled substance.
Some experts in the field, though, were angered by the agency's unusual move to ignore its advisers.
"If the FDA was really interested in protecting the public, they would have said, 'No thanks ... we have too many people dying of opioids in this country to justify approving Zohydro,'" David Juurlink, director of pharmacology and toxicology at the University of Toronto, told the Milwaukee Journal-Sentinel. "Minus the pesky acetaminophen, plus the crushability, it's a disaster in the making."
The approval also marks a win for Alkermes ($ALKS), which provided some of the delivery technology used by Zohydro.
Zohydro will now go up against drugs like Vicodin, a combination of hydrocodone with a less powerful pain medication. The FDA recently proposed to move those combo pills up from a Schedule III classification to a more restrictive Schedule II category.
- here's the release from the FDA
- here's the story from Bloomberg