Naloxone Availability: FDA Meeting Next Week
A joint US Food and Drug Administration (FDA) advisory committee is meeting next Monday and Tuesday to discuss ways to increase the availability of the opioid overdose antidote known as naloxone as the opioid crisis continues.The meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) will consider various options for increasing access to naloxone, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death, according to briefing documents on the meeting.
“Because of the potential, significant costs, challenges, and burdens as well as unintended consequences that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages, unintended public health consequences), the committees will also be asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some patients receiving prescription opioids,” FDA said.
The voting question for the committees is: “Would labeling language that recommends co-prescription of naloxone for all or some patients prescribed opioids, or more targeted prescribing for patients otherwise at high risk for death from opioid overdose be an effective method for expanding access to naloxone and improving public health? If so, which populations do you believe should be included in such labeling?”
Earlier this week, Kaleo, the manufacturer of one of the automated naloxone injectors, cut the price of the kit of two doses from more than $4,000 to $178, with the launch of an authorized generic.
According to briefing documents, naloxone sales have doubled from about 2.5 million units sold in 2013 to about five million units sold in 2017.
The rise in sales comes as the estimated number of naloxone prescriptions dispensed from US retail pharmacies more than doubled from 134,000 in 2016 to 330,000 in 2017. And over 70% of total naloxone prescriptions dispensed in 2017 were for the FDA-approved nasal spray formulation of naloxone.
To that end, FDA is making a case for and explaining how companies can turn their naloxone products into over-the-counter (OTC) drugs as part of a push to increase availability.
To facilitate OTC naloxone availability, the agency’s Nonprescription Model Drug Facts Label Project decided that FDA itself would design a model drug facts label and then iteratively refine and evaluate consumer comprehension of the label through a contract with a consumer behavior research firm.
After completion of the study report, if the study is determined to be successful from an independent review of the data, the resulting label could be used by any sponsor as an already-approved template, the agency added.
Meeting Materials