Opioid makers not fully responsible for abuse prevention, says FDA panel

After two days of discussions on how to urge appropriate use, preventillegal abuse and encourage more comprehensive trials of opioid drugs, the US Food and Drug Administration's Anesthetic and Life Support Drugs Advisory Committee decided there were huge knowledge gaps and unmet needs around pain management, reports the Marketletter's Washington correspondent.

The panel, whose ranks were swelled by pediatricians, substance-abuse experts and pain-management specialists, first grappled with the question of whether clinical trials of opioid drugs should target specific populations or indications.

Most marketed products have been studied for broad pain-relief indications in varied patient populations. While this may reflect actual clinical practice, it will not easily show the drug's efficacy, commented Gerald DalPan, a medical officer in the FDA's division of anesthetic, critical care and addiction drug products. Also, most recent trials do not have outcomes data for patients who take opioids chronically.