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FDA panel favors co-prescribing overdose reversal drug naloxone with painkillers

Advisory committees to the U.S. Food and Drug Administration voted 12 to 11 in favor of prescribing naloxone, an opioid overdose reversal medicine, along with prescription opioid painkillers.

The U.S. regulator's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee considered logistical, economic and harm reduction aspects of co-prescribing naloxone with all or some opioid prescriptions to cut the risk of overdose death.

Martin Garcia-Bunuel was one of the panelists who voted in favor of adding labeling that recommends co-prescribing naloxone with opioid painkillers, The Washington Post reported. Garcia-Bunuel said the recommendation could promote discussion between doctors and patients around the use of naloxone.

On the other hand, Raeford Brown, who chaired the two-day meeting, said "co-prescribing is the least-effective method we talked about in terms of actually providing product to the patient," the report noted. Some committee members were concerned that such a recommendation would result in naloxone shortages.

Earlier this month, the Institute for Clinical and Economic Review released its final report on extended-release opioid treatments and prescribed policies to improve the cost-effectiveness of these therapies. In October, the U.S. pricing watchdog found that the cost of treatments for opioid use disorder far exceeds its thresholds for cost-effectiveness. ICER also found insufficient evidence that extended-release medications provide greater net health benefit over buprenorphine and naloxone, sold by Indivior PLC as Suboxone.

According to the FDA, opioid use disorder affects more than 2 million Americans, and at least 72,000 people died from an overdose in 2017.

In November, eight medical device companies, ranging from therapeutics to diagnostic capabilities, have been selected by the FDA for their submitted development plans to help combat the opioid crisis.