Naloxone, packaged with instructions, is considered one of the items given out by the Baltimore Harm Reduction Coalition outreach employees.
Amy Davis | Baltimore Sun | Getty Images
The Food and Drug Administration on Tuesday indicated it’d approve over-the-counter nasal sprays and autoinjectors that prevent opioid overdoses, a part of its efforts to expand access to a life-saving drug called naloxone.
The FDA, in a preliminary assessment, said nasal spray containing as much as 4mg of naloxone and autoinjectors that administer as much as a 2 mg dose of the drug is likely to be protected and effective for people to self administer and not using a prescription.
“We consider the prescription requirement for these naloxone products won’t be obligatory for the protection of the general public health,” the agency stated in a federal register notice published Tuesday, but stressed that it needed more data to make a definitive conclusion.
Opioid overdose deaths surged 65% in the course of the Covid-19 pandemic from 47,000 in 2019 to just about 78,000 in 2021, in accordance with data from the Centers for Disease Control and Prevention. Greater than 564,000 people have died from opioids within the U.S. since 1999 in three waves — first from prescription opioids, then from heroin and most recently from fentanyl.
The Trump administration declared the opioid crisis a public health emergency in 2017. The Health and Human Services Department has renewed the declaration every 90 days since then. The Biden administration prolonged the emergency again in September.
FDA Director Robert Califf, in an announcement Tuesday, said the regulator is in search of ways to forestall opioid deaths by expanding access to naloxone. The FDA is encouraging manufacturers to submit applications for nonprescription use of naloxone products.
Naloxone is a drugs that rapidly reverses overdoses by binding to opioid receptors. It could quickly restore normal respiration in someone who’s either respiration slowly or in no way resulting from an opioid overdose, in accordance with the National Institute of Drug Abuse.
The FDA first approved a single-use autoinjector containing naloxone in 2014 called Evzio, and a single-dose nasal spray called NARCAN in 2015. They each require prescriptions.
