The FDA will address new ways to increase the availability of naloxone, during a 2-day advisory committee meeting in December.
The FDA will address new ways to increase the availability of naloxone (Narcan and Evzio), during a 2-day advisory committee meeting in December. According to the FDA Commissioner Scott Gottlieb, MD, the drug is a critical tool for individuals, families, first responders, and communities to help reduce deaths from opioid overdose.
In a prepared statement, Gottlieb said there is an urgency in making naloxone more accessible. He noted that the number of overdose deaths from prescription and illicit opioids doubled from 21,089 in 2010 to 42,249 in 2016.
Narcan Nasal Spray and the Role of the Pharmacist
During the planned meeting, FDA officials will consult with external advisors from the agency’s Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees to consider various options that would help naloxone become more accessible. According to Gottlieb, the advisors will assist the FDA in weighing logistical, economic, and harm reduction aspects of different strategies. Meeting participants will also consider whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death.
“There is the potential for significant costs and burdens that may be associated with naloxone co-prescribing. These include the direct economic costs to consumers and health systems. They also include practical considerations such as the need for manufacturing volume growth for naloxone, and the risk of drug shortages of this product that could come from a sudden spike in prescribing,” said Gottlieb, in his statement.
FDA officials and advisors are expected to evaluate these and other considerations, as part of their effort to consider any potential challenges to wider co-prescribing of naloxone for all or some prescription opioid patients.
"We plan on discussing the potential development of OTC naloxone at the upcoming meeting," said Gottlieb, in his statement. "Another topic we plan to discuss is the work that many organizations and local municipalities across the U.S. have done to develop programs for making naloxone available in the community. We hope to glean insight from these efforts to further our own goals at expanding naloxone availability."
The meeting is scheduled to be held at the FDA's headquarters in Silver Spring, MD, and will be open to the public.
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths [news release]. Silver Spring, MD; October 23, 2018: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624053.htm. Accessed October 23, 2018.