March 29, 2023
NEXT Distro/Unsplash
Narcan temporarily blocks the effect of opioids and helps a person to start breathing again when they overdose.
The leading version of naloxone, the drug used to reverse opioid overdoses, was approved to be sold over the counter Wednesday by the U.S. Food and Drug Administration. Public health officials hope the move will help reduce overdose deaths, which have doubled nationally since 2015.
The Narcan nasal spray will become the first naloxone product to be sold without a prescription in the U.S. – although many states, including Pennsylvania and New Jersey, have standing orders that allow people to access the life-saving medication without a script.
Naloxone, commonly referred to by its brand name Narcan, temporarily blocks the effect of opioids and restores breathing when people overdose.
There were more than 101,750 reported fatal overdoses between October 2021 and October 2022, according to the FDA. A majority of the deaths were caused by synthetic opioids like fentanyl. Prescription opioids like oxycodone also led to overdose deaths. Fatal overdoses particularly have surged since the COVID-19 pandemic began.
"Today's approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it's available and help reduce opioid overdose deaths throughout the country," said FDA Commissioner Dr. Robert M. Califf.
Over-the-counter Narcan will become available in pharmacies, convenience stores, supermarkets, gas stations and online by late summer, according to Emergent BioSolutions, the company that manufactures the nasal spray. The company did not say how much it will cost.
Advocates have pushed for expanded access to naloxone, saying it is important for people who are most likely to be around someone who overdoses to have it at the ready. That includes drug users and their families.
Dr. Scott Hadland, an addiction specialist at MassGeneral Hospital for Children in Boston, told NBC that overdoses have been increasing among teenagers and young adults. Most overdose deaths occur at home, where there often is someone nearby who could deliver naloxone.
"Yet most young people who overdose never receive Narcan and are pulseless by the time EMS arrives," he said. "Making it available over the counter will provide a new avenue of access, especially for young people and families who haven't been the targets of our widespread efforts to distribute Narcan across the country."
In Pennsylvania and New Jersey, anyone can purchase naloxone from a pharmacy, either with a prescription or through the states' standing orders, which allow pharmacists to dispense it without requiring an individual prescription. The nonprofit NEXT Distro also will mail naloxone to people for free after they go through an online training program.
Jose Benitez, lead executive officer at Prevention Point Philadelphia, a nonprofit that works to prevent fatal overdoses by distributing free naloxone and providing other services, told the Associated Press that over-the-counter access may help people who don't seek help from organizations Prevention Point, or lack access to them.
Some people don't want to go to a pharmacy to obtain naloxone because they don't want their insurers to know they're getting it, he explained. "Putting it out on the shelves is going to allow people just to pick it up, not have stigma attached to it and readily access this life-saving drug," he said.
The OTC Narcan will come in packaging that includes images and detailed instructions on how to administer the drug. As a part of the FDA approval process to switch the nasal spray to an OTC designation, Emergent BioSolutions had to show that it not only is safe and effective, but that its directions can be easily followed without the supervision of a health care professional.
Earlier this month, the FDA moved to restrict the importation of xylazine, an animal tranquilizer that increasingly has been mixed with opioids, and can mask the effects, making it difficult to know whether an initial dose of the overdose antidote worked. Federal lawmakers also are making a bipartisan push to classify 'tranq dope' as a Schedule III controlled drug.
The most common signs of an opioid overdose are slow, shallow or no detectable breathing; pale, blue, purple, or gray lips, face or nail beds; and unresponsiveness or unconsciousness. Other signs are loud snoring or gurgling noise; rigid arms and chest; and slow or no pulse.
After administering the Narcan nasal spray, people must call 911 for medical assistance.
After receiving the medication, the opioid user may experience severe withdrawal symptoms including body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
Under the 'Good Samaritan' law, anyone who calls 911 for emergency medical services for someone who is overdosing and stays with them until help arrives can not face certain criminal charges.
