(Adds details, background)
Sept 11 (Reuters) - Collegium Pharmaceutical Inc's COLL.O
experimental opioid painkiller moved one step closer to approval
after a panel of outside advisers to the U.S. Food and Drug
Administration unanimously voted in favor of the drug.
The FDA panel's vote also was contrary to a recommendation
by FDA staff, which on Wednesday expressed concerns that the
oral painkiller could be wrongly used, leading to an overdose.
The panel voted 23 to 0 in favor of approving the drug.
The FDA is not obliged to follow the advice of its advisory
panels, but usually does.
Collegium's long-acting experimental oxycodone pill, to be
sold as Xtampza if approved, is meant to be taken after a meal
to provide maximum pain relief.
The FDA staff had said if the drug was taken without food,
it could lead to insufficient pain control, which in turn could
contribute to overdosing and misuse.
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.
An estimated 46 people die everyday in the United States
from overdosing on opioid painkillers, according to The Centers
for Disease Control and Prevention.
Collegium has proposed to make clear on the label that
Xtampza, its lead drug in development, should only be taken
after eating.
The FDA panel's vote of approval for Xtampza is also a
positive for other companies developing abuse-deterrent version
of painkillers.
Pernix Therapeutics Holdings Inc PTX.O , Egalet Corp
EGLT.O , KemPharm Inc KMPH.O , IntelliPharmaCeutics
International Inc I.TO , Pain Therapeutics Inc PTIE.O and
Acura Pharmaceuticals Inc ACUR.O are among the drugmakers
developing abuse-deterrent painkillers.
However, another FDA panel on Thursday voted against
approving Purdue Pharma's fast-acting opioid painkiller due to
concerns of overdosing. ID:nL4N11G5HT
Trading in Collegium's shares were halted through Friday,
ahead of the vote. They closed at $13.45 on Thursday.