Collegium Painkiller Given Green Light from FDA Panel

The experimental opioid painkiller by Collegium Pharmaceutical has moved another step closer to FDA approval after a panel of expert advisers to the United States Food and Drug Administration voted unanimously in favor of its painkiller.

The panel’s vote was contrary to a recommendation by staff at FDA, which on Wednesday had expressed a concern that the painkiller, which is administered orally could be used incorrectly leading to overdoses.

The expert panel voted 23 to 0 in support of approving the drug. However, the FDA is not obliged to follow advice of the advisory panel but it usually does.

Collegium’s oxycondone long acting experimental pill, to be sold under the commercial name Xtampza if it is approved, is meant to be administered after eating a meal to provide its maximum pain relief.

The FDA staff said if the medication was taken without consuming food beforehand it could lead to insufficient pain control, which could in turn contribute to misuse and overdosing.

Opioid, a group of drugs that includes heroin and other prescription painkillers have a long history of abuse. An overdose of these drugs could produce a euphoric high and even disrupt parts of the users’ brain that controls breathing.

It is estimated that 46 people die each day in the U.S. from an overdose of painkillers that are opioids according to the Center for Disease Control.

Collegium proposed to make it clear on its label that Xtampza, its leading drug in its development chain should only be taken following a meal.

The panel’s approval for Xtampza is a positive for other pharmaceuticals developing painkiller that are abuse deterrent versions.

Pernix Therapeutics, Egalet Corp, IntelliPharmaCeutics International, KemPharm Inc, Acura Pharmaceutical and Pain Therapeutics are amongst the drug makers developing painkillers that are abuse deterrent.

However, another panel of FDA advisers voted on Thursday against approving a Purdue Pharma opioid painkiller that is fast acting due to overdosing concerns.



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