Overdose-reversing nasal spray Narcan safe to sell over the counter, US experts say
Sign up now: Get ST's newsletters delivered to your inbox
The US saw at least 107,000 deaths due to drug overdose in 2021.
PHOTO: NYTIMES
WASHINGTON – Two federal panels of addiction experts on Wednesday unanimously recommended that Narcan, the overdose-reversing nasal spray, be made widely available without a prescription, a significant step in the effort to stem skyrocketing drug fatalities.
Making Narcan an over-the-counter drug has been urged by doctors, patient advocacy groups and the Biden administration.
The unanimous vote by the committees, which advise the Food and Drug Administration (FDA), makes it highly likely that the FDA will approve an over-the-counter version of the drug, also known generically as naloxone, in March.
It could potentially become available in vending machines, schools, convenience shops, big-box stores and supermarkets by summer.
As the overdose crisis worsened in recent years, the use of Narcan has become commonplace, but the millions of doses have been administered largely by outreach workers, healthcare providers and emergency responders.
For people who use drugs, as well as their friends and relatives, ready access to the prescription medication has been elusive.
Many public health experts believe that if more people were to have the spray readily available at home, or in their pockets or knapsacks, many fatalities could be averted.
The Biden administration has made expanding access to the medicine a priority in its efforts to combat the overdose crisis, which reached a record 107,000 deaths in 2021.
In recommending that the spray become as easily available as ibuprofen, the 19 voting panellists determined that naloxone, which was approved as an overdose-reversal injection in 1971, is abundantly safe and effective even in infants, with almost no potential for misuse or abuse.
And, the panels concluded, naloxone does not require medical training to use.
Side effects, typically symptoms associated with withdrawal, were relatively negligible compared with the medicine’s far greater life-saving benefit, panel members said.
Naloxone, which comes in a nasal spray, a vial and preloaded syringes, is believed to have saved hundreds of thousands of lives.
The unusual unanimity of the vote “underscores the importance of moving this drug to greater access and also highlights the terrible risk of not acting in terms of making the drug more accessible”, said Dr Maria Coyle, chair of the advisory panel and an associate clinical professor at the Ohio State University College of Pharmacy. NYTIMES