FDA panel votes for prescribing naloxone with opioids

(Reuters) - An advisory panel to the U.S. Food and Drug Administration on Tuesday recommended prescribing the opioid overdose reversal drug, naloxone, along with addictive painkilllers.

The panel, which concluded a two-day discussion on ways to make the potentially life-saving drug readily available, voted 12-11 in favor of labeling changes for opioids that recommend co-prescribing the overdose antidote.

The recommendation of the panel underscores concerns about the growing opioid overdose epidemic that claimed the lives of more than 49,000 Americans last year.

“I think the labeling, if done properly, will help create a conversation, standardizes a conversation, that protects patients,” Martin Garcia-Bunuel, a panel member who voted in favor, said, while highlighting the need for alleviating the social stigma associated with opioid overdose.

Naloxone, when administered quickly, helps reverse the effects of opioid overdose and thereby save lives.

Branded versions for treating opioid overdose include Adapt Pharma’s Narcan nasal spray and Kaleo Inc’s Evzio auto-injector.

Naloxone is currently made available through education on overdose, distribution and prescription programs in pain clinics, opioid treatment programs, as well as “take-home” programs for high risk patients.

DECEMBER 18, 2018

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