FDA Advisory Panel Votes in Favor of Approving New Opioid Painkiller

An advisory panel to the Food and Drug Administration (FDA) has voted in favor of approving a new opioid painkiller made by Collegium Pharmaceuticals. The panel’s unanimous vote was contrary to a recommendation by FDA staff, according to Reuters.

FDA staff members last week expressed concern that the painkiller could be wrongly used and lead to an overdose. The FDA does not have to follow the advice of its advisory panels, but generally does.

The new long-acting drug will be called Xtampza ER if it is approved. It should be taken with food to be most effective. The FDA staff said if the drug is taken without food, it might not provide sufficient pain control. This could contribute to overdosing and misuse, they said. The company said it will make clear on the label that the drug should only be taken after eating.

Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone, according to a company news release. It is meant for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

An FDA panel last week voted against approving another opioid painkiller because of concerns of overdosing. The drug, which would be sold as Avridi if approved, is made by Purdue Pharma. It is an abuse-deterrent fast-acting form of oxycodone, Reuters reports.