(Adds Zogenix comment, updates share price)
By Susan Heavey
WASHINGTON, March 28 (Reuters) - 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 stemming from the abuse of opioids in the New England
state.
It is the latest salvo in the ongoing battle over Zohydro's
launch as the United States 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 6.7 percent in afternoon trade on the Nasdaq.
Bradley Galer, chief medical officer of Zogenix, said
Massachusetts officials are misguided about Zohydro's potency
and dosage, and noted that other painkillers without
abuse-resistant technologies are already on the U.S. market.
"It's not unusual whatsover," Galer told Reuters in an
interview on Friday.
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
formularies.
Zohydro is a extended-release 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
bleeding.
But critics worry that with no built-in abuse deterrents,
Zohydro will be a draw for addicts looking for an easy fix.
Massachusetts' Patrick, in his speech, called Zohydro "a
dangerously addictive pharmaceutical painkiller, and said it
will not be sold in his state "until it is available in an
abuse-deterrent form." He also supported calls for the FDA to
reverse its approval of the drug and said he has written members
of Congress and the Department of Health and human Services,
which oversees the FDA.
The fate of Zohydro is key for Zogenix, which has only one
other FDA-approved product, although it is developing others.
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.
Galer said Zogenix is "not concerned" about the competition.
Zogenix, in its statement, said it looked forward to
reviewing "the safe use measures already in place" for Zohydro
with Massachusetts officials, although Galer said no meeting had
been set yet.
(Reporting by Susan Heavey; Editing by Bernard Orr)
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