April 15 A U.S. federal court granted Zogenix
Inc a preliminary injunction against a ban blocking the
sale of its controversial opioid painkiller, Zohydro, in
Massachusetts, citing public interest.
Last week, the company had sought a restraining order
against the ban announced by Massachusetts Governor Deval
Patrick, who formally declared a public health emergency
stemming from the abuse of opioids.
The U.S. District Court of Massachusetts struck down 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. (link.reuters.com/par58v)
" ... 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. For the same
reason, the injunction is in the public interest," Judge Rya
The order is stayed until April 22.
The injunction comes in the midst of a furor over Zohydro,
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.
Zohydro, Zogenix's sole product on the market, was approved
by the FDA last year despite objections by its advisory panel,
which expressed concern over the drug's potential for abuse.
The drug, an extended-release form of hydrocodone, has since
come under scrutiny from members of Congress, state attorney
generals, medical groups and experts seeking to block its use.
Unlike rival products such as AbbVie Inc's Vicodin
or UCB's Lortab, Zogenix's Zohydro does not contain
acetaminophen, a nonsteroidal anti-inflammatory drug linked to
liver damage and stomach bleeding.
Zogenix has defended the drug as a necessary option for
patients who cannot tolerate acetaminophen. But critics worry
that with no built-in abuse deterrents, Zohydro will be a draw
for addicts looking for an easy fix.
Zogenix shares closed down 4.5 percent at $2.34 on Tuesday
on the Nasdaq.
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 Natalie Grover in Bangalore; Editing by Savio