May 10 The U.S. Food and Drug Administration on
Friday denied Endo Health Solutions' petition to block
generic forms of its widely abused prescription pain drug Opana
ER, a surprise decision by an agency that has recently come down
hard on pain drugs to prevent their abuse.
Prescription drug abuse leads to more deaths in the United
States than heroin and cocaine combined, according to the U.S.
Centers for Disease Control and Prevention.
The company had argued that its reformulated version of
Opana ER, a powerful opioid painkiller containing oxymorphone,
would be more difficult to abuse than the original version, and
therefore asked that generics of the earlier version be barred
from the market.
However, the FDA determined that the original formulation of
the drug had not been withdrawn from the market for reasons of
safety or effectiveness and so its generic forms could continue
to be approved and marketed. ()
The regulator also noted that reformulated Opana ER could
still be manipulated for abuse in certain ways and that one of
the new version's post-marketing investigations had raised the
possibility that it may be more susceptible to abuse via
injection than the original.
The agency's decision comes a month after it said it would
not approve any generic versions of the original form of the
pain medication OxyContin, which was widely abused because it
could be crushed and then snorted or injected to produce a quick
That decision had led many analysts to expect that the FDA
would side with Endo against the generics.
This expectation was also due to the formulations of Opana
ER and OxyContin being very similar, said RBC Capital Markets
analyst Shibani Malhotra.
"Implicitly, what the agency has done by not blocking Opana
ER generics is (to say) that there is no benefit to using Opana
ER when there are generics available," Malhotra said.
Endo on Friday said it would explore all options to mitigate
the effect of the FDA decision.
Opana ER brought in sales of about $299.3 million to Endo in
2012, down 22 percent from the earlier year because of the
introduction of cheaper, copycats of the drug.
Following Friday's FDA decision, Endo said it estimates its
2013 net sales from Opana ER would fall by about $120 million,
reducing operating profit by about 55 cents per share.
Michael Tong of Wells Fargo said the decision was a positive
for Impax Laboratories Inc, which markets all strengths
of generic Opana ER.
Endo shares closed down 5 percent at $34.97 on the Nasdaq on
Friday. Impax shares closed up 8 percent at $17.40.