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FDA declines to approve
Mallinckrodt's abuse-deterrent opioid painkiller
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[December 12, 2018]
(Reuters) - The U.S. Food and Drug
Administration has declined to approve an abuse-deterrent version of
Mallinckrodt Plc's opioid painkiller Roxicodone, saying some parts of
the company's application need further evaluation.
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 The treatment is a reformulated version of the company's commonly
abused painkiller Roxicodone, intended to make the drug less
desirable and more difficult to be abused by snorting or injecting.
Mallinckrodt's shares fell 4.4 percent to $20.02 in premarket
trading on Wednesday.
The decision comes after an advisory panel to the FDA voted 10-7 in
favor of the drug, saying it should be labeled as abuse deterrent
only by the nasal route.
"While all the abuse deterrent properties of this medication are
perhaps not as robust as we might like, it is an important advance
over the existing formulation," Brian Bateman, a panel member who
had voted in favor of the drug's approval, had then said.
Mallinckrodt is one of the nation's largest manufacturers of
oxycodone - the most commonly abused prescription painkiller after
hydrocodone in 2016.
The panel members, during the Nov. 14 meeting, also raised concerns
of Mallinckrodt's treatment creating the same problem as Endo
International Plc's reformulated Opana ER did.
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Endo withdrew the drug from the market last year after postmarketing
data showed that while the rates of nasal abuse associated with
Opana fell, rates of intravenous abuse rose. (https://bit.ly/2QGXzS5)
Mallinckrodt, Endo and other drugmakers including Johnson & Johnson
have been sued by state and local governments alleging the companies
of contributing to the national drug addiction epidemic through
their marketing and promotion of opioids.
"We are evaluating the FDA's letter and will request a meeting in
the coming weeks to discuss it further," Matt Harbaugh, president of
the company's specialty generics unit said in a statement.
(Reporting by Tamara Mathias and Saumya Sibi Joseph in Bengaluru;
Editing by Saumyadeb Chakrabarty)
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