(Corrects analyst's name in 12th paragraph to Smith from Cox)
By Susan Heavey
WASHINGTON, March 28 Officials in Massachusetts
have blocked sales of Zogenix's controversial but
U.S.-approved painkiller Zohydro, prompting the drugmaker to
criticize what it called an "unprecedented action."
The state's ban "only serves to unfairly restrict patient
access," the company said in a statement late Thursday.
"Ultimately, the ban on the prescription medication will add to
patient suffering in the state," it added.
Massachusetts Governor Deval Patrick announced the Zohydro
ban in a speech on Thursday, formally declaring a public health
emergency resulting from the abuse of opioids in the New England
It is the latest salvo in the ongoing battle over Zohydro's
launch as the U.S. grapples with a wave of abuse of opioids, a
class of drugs that includes not only powerful prescription
painkillers but also heroin.
On Friday, shares of the San Diego, California-based company
were down 4 percent in early afternoon trade on the Nasdaq.
The federal Food and Drug Administration approved Zohydro
last year over the objections of its advisory panel, which
expressed concerns about the potential for abuse.
The drug has since come under further scrutiny from members
of Congress, dozens of state attorney generals, medical groups
and drug treatment experts seeking to block the drug even as the
FDA's top official has defended its action.
While the FDA approves drugs for sale in the United States,
it does not guarantee their availability. For example, health
insurance companies can exclude certain medications from their
Zohydro is a form of hydrocodone that, unlike rival products
such as AbbVie Inc's Vicodin or UCB's Lortab,
does not contain acetaminophen.
The company has defended the drug as a necessary option for
pain patients who cannot tolerate acetaminophen, a nonsteroidal
anti-inflammatory drug linked to liver damage and stomach
But critics worry that with no built-in abuse deterrents,
Zohydro will be a draw for addicts looking for an easy fix.
Rival Purdue Pharma has said it is working on a hydrocodone-only
drug that will be resistant to abuse, something Zogenix has also
pledged to do.
"Once/if the Purdue product is approved, possibly in 2015,
FDA could then rule that Zohydro is not as safe as the
abuse-deterrent product and either pull the drug's approval or
ask Zogenix to withdraw it voluntarily," Rob Smith, an analyst
with Capital Alpha Partners, said earlier this week.
Zogenix, in its statement, said it would "review the safe
use measures already in place" with Massachusetts officials.
(Reporting by Susan Heavey; Editing by Bernard Orr)