U.S. panel backs approval
of Egalet's abuse-resistant painkiller
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[August 05, 2016]
WASHINGTON (Reuters) - A U.S.
advisory panel on Thursday recommended approval of Egalet Corp's
long-acting opioid painkiller, Arymo ER, saying it dulls pain and could
deter abuse by addicts seeking a quick high.
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The panel recommended that the Food and Drug Administration (FAD)
approve the drug and said it deters, but does not eliminate, the
risk of abuse if addicts try to snort, chew or inject it.
The FDA is not obliged to follow the recommendations of its advisory
committees but typically does so.
Addicts frequently attempt to increase the speed with which opioids
get into their bloodstream by chewing or crushing the pills, or by
dissolving and injecting them.
Egalet's tablets are designed to be extremely hard, making them more
difficult to break down to extract the active ingredient. If brought
in contact with liquid they turn into a sticky gel difficult to
inject with a syringe.
In June a panel recommended approval of a long-acting,
abuse-deterrent opioid made by Pfizer Inc though it had reservations
about the drug's ability to curb all forms of abuse.
The panel also recommended approval of a long-acting opioid made by
Teva Pharmaceutical Industries Ltd and said it was likely to deter
abuse whether addicts sought to swallow, snort or inject it.
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The Centers for Disease Control and Prevention estimates that 78
Americans die every day from opioid overdose.
(Reporting by Toni Clarke; Editing by Sandra Maler and Andrew Hay)
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