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UPDATE 1-FDA delays ruling on Collegium's opioid painkiller

Published 2015-10-12, 05:14 p/m
UPDATE 1-FDA delays ruling on Collegium's opioid painkiller
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(Adds background, share reaction)
Oct 12 (Reuters) - Collegium Pharmaceutical Inc COLL.O
said the U.S. Food and Drug Administration said it would not be
able to complete its review of the company's opioid painkiller
by Monday.
The company's shares fell 8 percent in extended trading.
Collegium did not say if the FDA had given any reason for
not being able to complete the review by the set date of Oct. 12
or when it expected the review would now be completed.
urn:newsml:reuters.com:*:nGNXVEPCLa
Collegium's long-acting experimental oral opioid painkiller,
Xtampza, is meant to be taken after a meal for maximum effect.
A panel of outside advisers to the FDA had unanimously voted
in favor of the drug on Sept. 11. But, two days before that FDA
staff had said that if the drug was taken without food, it could
give insufficient relief, which could lead to overdosing.
urn:newsml:reuters.com:*:nL4N11H5E1
The abuse of opioids - a class of drugs that include heroin
and prescription painkillers - has long been a concern. An
overdose of such drugs can produce euphoric highs and even
disrupt parts of the brain that control breathing.
The FDA's ruling on Xtampza will be keenly watched by other
developers of abuse-deterrent versions of painkillers.
These include Pernix Therapeutics Holdings Inc PTX.O ,
Egalet Corp EGLT.O , KemPharm Inc KMPH.O , Pain Therapeutics
Inc PTIE.O and Acura Pharmaceuticals Inc ACUR.O .
Collegium's shares were trading at $18.25 after the bell.
They closed at $20.09 on the Nasdaq.

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