Endo Health Solutions Inc.
ENDP announced today that its subsidiary, Endo Pharmaceuticals Inc.,
has filed suit against the U.S. Food and Drug Administration (FDA) seeking a
formal determination whether the original formulation of OPANA^® ER
(oxymorphone HCl) was voluntarily removed from the market in 2012 for reasons
of safety involving the misuse of the drug; and FDA's immediate suspension of
any abbreviated new drug applications (ANDAs) for generic versions of
non-tamper resistant formulations of extended-release oxymorphone HCl until
FDA has made a determination as to whether the original formulation of OPANA
ER was withdrawn from sale for safety reasons. There is currently a
non-tamper resistant generic of extended-release oxymorphone available in
7.5mg and 15mg dosage strengths, and if the FDA does not promptly suspend the
approval of all non-tamper resistant formulations, all doses of the product
will be available in non-tamper resistant versions in January 2013.
Endo reformulated OPANA ER to a version designed to be crush-resistant and
launched this reformulated version in March 2012. Current data monitoring
abuse rates show a substantial decrease in abuse since the launch of the
reformulated product, while simultaneously showing a more than 122 percent
increase in abuse rates of the 7.5mg and 15mg non-tamper resistant extended
release oxymorphone HCl.
The lawsuit, filed in the U.S. District Court for the District of Columbia, is
based on the failure of the FDA to meet its legal obligation to determine in a
timely manner whether the old formulation of OPANA ER was withdrawn from the
market for reasons of safety. Since its launch, Endo has collected
surveillance data on the rates of abuse of oxymorphone HCl from two national
programs – the first includes surveillance of substance abusers and the second
collects data from U.S. Poison Control Centers. The data show a 59 percent
drop in abuse rates of the reformulated OPANA ER which is designed to be
crush-resistant. The same data demonstrate a 122 percent increase in abuse
rates of non-tamper resistant extended-release oxymorphone HCl.
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