The Food and Drug Administration (FDA) has approved a nasal spray version of naloxone—the life-saving medication that can reverse the effects of an opioid overdose by restoring breathing and preventing death. The approval marks another gain in the effort to curb the opioid overdose epidemic.
Narcan® nasal spray, the newly approved version of naloxone, requires no additional assembly and delivers a consistent, measured dose when used correctly. The spray is delivered to an overdose victim through one nostril and can be repeated if necessary. Anyone, including those without medical training, can effectively administer Narcan® nasal spray.
“The AMA applauds the FDA for approving the nasal spray version of naloxone,” Patrice A. Harris, chair-elect of the AMA, said in a press release. The FDA’s “swift action will widely increase accessibility to this medication that will help prevent more opioid-related overdoses and save more lives.”
When a person overdoses on opioids, their breathing may become shallow or even stop. If someone administers naloxone quickly and safely, overdose effects can be countered often in less than two minutes.
“While naloxone will not solve the underlying problems of the opioid epidemic,” said Stephen Ostroff, MD, acting commissioner of the FDA, “we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”
Combatting the opioid overdose epidemic
Earlier this year, the AMA convened the Task Force to Reduce Opioid Abuse to identify best practices to curb opioid abuse and implement those practices across the country. The Task Force has focused not only on increasing access to naloxone but also on increasing the number of physicians who are registered for and use of prescription drug monitoring programs (PDMP), enhancing physician education, reducing the stigma of opioid disorders and improving access to comprehensive pain management.
“With 44 people dying each day from opioid-related overdose,” Dr. Harris said, “we are committed to expanding our efforts aimed at addressing prescription drug abuse and diversion and putting an end to this serious public health epidemic.”
Recently, the AMA adopted new policy at its 2015 Interim Meeting to encourage manufacturers or other qualified sponsors to pursue the FDA’s application process for approving access to over-the-counter naloxone.
Following the formation of the task force, Dr. Harris detailed 4 ways physicians can take action in an AMA Wire® Viewpoints post. “This drug [naloxone] has saved tens of thousands of lives in communities across the country,” she wrote. “Now it’s time for us physicians to help increase the number of lives saved by co-prescribing naloxone when it is clinically indicated.”