As part of its attempts to increase access to the life-saving medication naloxone, the Food and Drug Administration on Tuesday hinted that it would approve over-the-counter nasal sprays and autoinjectors that prevent opioid overdoses.
According to a preliminary analysis by the FDA, naloxone nasal sprays up to 4 mg and autoinjectors up to 2 mg may be safe and efficient for people to self-administer without a prescription.
The agency said in a federal register notice posted on Tuesday that it “believes the prescription requirement for these naloxone products might not be necessary for the protection of the public health,” but emphasised that it needed more information to draw a firm conclusion.
According to data from the Centers for Disease Control and Prevention, the number of opioid overdose deaths increased by 65% during the Covid-19 epidemic, from 47,000 in 2019 to around 78,000 in 2021. Since 1999, more than 564,000 Americans have died from opioid overdoses, with the first wave being caused by prescription opioids, the second by heroin, and the third by fentanyl.
The opioid problem was deemed a public health emergency by the Trump administration in 2017. Since then, the proclamation has been reaffirmed by the Department of Health and Human Services every 90 days. In September, the Biden administration renewed the state of emergency.
In a statement released on Tuesday, FDA Director Robert Califf said the agency is exploring for ways to reduce opioid overdose deaths by increasing naloxone availability. The FDA is urging manufacturers to submit requests for naloxone drugs to be used without a prescription.
Naloxone is a drug that works by interacting with opioid receptors to quickly reverse overdoses. According to the National Institute on Drug Abuse, it can swiftly bring someone who is breathing slowly or not at all as a result of an opioid overdose back to regular respiration.
Evzio, a single-use autoinjector containing naloxone, received FDA approval in 2014; NARCAN, a single-dose nasal spray, received FDA approval in 2015. Both of them call for prescriptions.