(Adds background, information from court ruling and company,
share activity, in paragraphs 2, 7 and 9)
By Susan Kelly and Natalie Grover
April 15 A U.S. District Court judge on Tuesday
stopped Massachusetts from implementing a ban on the sale of
Zogenix Inc's prescription painkiller Zohydro, saying
federal law superseded the state's action.
The company's shares climbed about 9 percent to $2.54 in
Massachusetts Governor Deval Patrick had announced a ban on
the drug, formally declaring a public health emergency on March
27 stemming from abuse of opioids in the New England state.
The U.S. District Court for Massachusetts granted a
preliminary injunction against the ban, saying that by imposing
its own conclusion about the safety and efficacy of Zohydro, the
state was obstructing the U.S. Food and Drug Administration's
constitutionally mandated charge.
The federal court order goes into effect on April 22.
"Although the ban may prevent someone from misusing the
drug, the ban prevents all in need of its special attributes
from receiving the pain relief Zohydro ER offers," Judge Rya
The injunction comes in the midst of a furor over Zohydro as
the United States grapples with a rise in opioid abuse. The
class of drugs includes not only powerful prescription
painkillers but also heroin. Massachusetts has seen a spike in
the number of opioid- and heroin-related deaths.
Zohydro, an extended-release form of hydrocodone, has come
under scrutiny from members of the U.S. Congress, state
attorneys general, medical groups and drug treatment experts
seeking to block its use.
Although intended for release over a 12-hour period, the
medicine can be crushed and inhaled or injected, making a full
dose available immediately.
FDA last year approved Zohydro, Zogenix's sole product on
the market, despite concerns from an advisory panel over the
drug's potential for abuse.
Zogenix maintains the drug is a necessary option for
patients with severe, around-the-clock pain who cannot tolerate
"Today's legal ruling was a positive step forward for
Massachusetts patients," said Zogenix Chief Executive Roger
Unlike competing products such as AbbVie Inc's
Vicodin and UCB's Lortab, Zohydro does not contain
acetaminophen, which has been linked to liver damage.
FDA, in a statement, said it is following the legal
proceedings in Massachusetts and remains concerned about efforts
by states to ban FDA-approved drugs.
"Both the prevention of prescription opioid abuse and
appropriate pain management are top public health priorities at
FDA. Actions to advance one should not impede the other," the
The case was in Re: Zogenix Inc vs Deval Patrick in the U.S.
District Court, District of Massachusetts, No. 14-11689-RWZ
(Reporting by Susan Kelly in Chicago and Natalie Grover in
Bangalore; Additional reporting by Toni Clarke in Washington;
Editing by Savio D'Souza, Jonathan Oatis and Mohammad Zargham)