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 The FDA's approval of the drug has drawn a flood of
criticism, including protests from the attorneys general of 28
states as well as dozens of groups representing doctors and
addiction treatment specialists who are concerned that Zohydro will
set off a wave of addiction similar to problems with the original
form of OxyContin, another opioid.
These critics have petitioned the FDA to consider pulling the drug's
marketing approval.
FDA Commissioner Margaret Hamburg, testifying at a Senate hearing,
acknowledged that Zohydro is "a powerful drug" but said "...that if
appropriately used, it serves an important and unique niche with
respect to pain medication and it meets the standards for safety and
efficacy."
Her comments to the Senate Health, Education, Labor and Pensions
Committee come barely a week after Zogenix said it was making the
painkiller available at "select pharmacies" following the drug's FDA
approval in October.
In approving the drug, the FDA overruled its panel of outside
advisers, who had recommended against approval, citing safety
concerns about the potential for abuse.
Shares of Zogenix rose more than 5 percent after Hamburg's comments,
before slightly paring gains to close up 4.6 percent at $3.67 on the
Nasdaq.
In her comments at Thursday's hearing, Hamburg said the FDA,
in approving Zohydro, recognized "...its addiction potential and
understanding, of course, the broader context of the serious problem
of opioid medication abuse and misuse in this country."
Zogenix last week, in its statement on quarterly results, said it is
"taking a measured approach to commercialization." Representatives
for Zogenix told Reuters on Thursday that the company had no further
comment.
A recent study of government data found that, on average, more than
12 million people age 12 and older were estimated to have used
prescription opioids at least once a year to get high.
Senators at the committee's hearing echoed worries about abuse,
noting the Zohydro is not made in a way to thwart crushing or
chewing of such drugs to get a high.
"The concern that I think a number of us have ... (are) about the
implications of allowing this new product on the market without
these abuse deterrent properties," said Senator Robert Casey, a
Democrat from Pennsylvania on the panel.
Senator Joe Manchin of West Virginia, whose state has been
particularly hard-hit by prescription drug abuse, earlier this week
called on U.S. Health and Human Secretary Kathleen Sebelius to
overturn the FDA's approval.
"Americans are abusing, and (in) many cases dying, at an alarming
rate from highly addictive pain medicine, and it is shameful that
the FDA would ignore its own experts to approve this drug," Manchin
said in a statement after the hearing. He later introduced
legislation that would ban Zohydro.
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Hamburg said unlike other approved hydrocodone drugs, Zohydro
does not contain acetaminophen, which can be toxic to the liver. She
also said other factors, including doctors' prescribing practices,
play a role in drug abuse.
Abuse of OxyContin became so widespread that manufacturer Purdue
Pharma changed its formula in 2010 so that the drug could not be
injected or snorted as easily. On Wednesday, Purdue said it was
moving ahead with an abuse-resistant rival to Zohydro.
Zogenix last week also said it is making progress on another version
of Zohydro to deter abuse.
"I would love if we had abuse-deterrent formulations that were
actually meaningful and effective at deterring abuse in all
instances. We are moving in that direction," Hamburg told lawmakers.
"Right now, unfortunately, the technology is poor."
She added that the FDA is working on guidelines to help
manufacturers come up with more effective abuse deterrents but gave
no timeline for when the guidelines would be finalized.
Developing more non-opioid pain drugs could also help prevent
misuse, she said.
"Acute and chronic pain needs to be treated. Opiates are very
effective for acute pain, less effective for chronic pain, but we
don't have a lot of good alternatives at the present time," she told
the Senate panel.
Hamburg also said more attention needs to be paid to the
overdose-reversal medication called naloxone, which could save more
lives if it was easier to use and more widely available.
The FDA is urging drugmakers to develop other forms of the
injectable drug such as a nasal spray or an automatically injectable
version, she added and has been encouraged by their response, she
said.
(Reporting by Susan Heavey; editing by
Michele Gershberg, Bill Trott and Leslie Adler)
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