FDA Approves Over-The-Counter Sale Of Narcan To Combat Opioid Overdoses
The overdose antidote maker Emergent BioSolutions says that it expects its naloxone nasal spray to be available for purchase without a prescription by the summer but has not announced pricing yet.
The Washington Post:
Drug Overdose Antidote Narcan Goes Over-The-Counter
Narcan, the lifesaving nasal spray that reverses opioid overdoses, has been approved for purchase without a prescription, the Food and Drug Administration announced on Wednesday. The long-awaited decision could dramatically broaden the availability of Narcan, a spray version of naloxone, which requires no special training to administer, and has already been credited with saving thousands of lives from opioid overdoses. The approval came on the same day Homeland Security Secretary Alejandro Mayorkas testified to a Senate panel that the record number of Americans dying of fentanyl overdoses is the “single greatest challenge we face as a country.” (Ovalle, 3/29)
NPR:
Narcan, Overdose-Reversing Drug, Is Approved For OTC Sales By The FDA
Emergent BioSolutions, the drug company that produces Narcan, said on Wednesday that it hoped to make the nasal spray available on store shelves and at online retailers by late summer. It did not immediately say how much it would cost. "Today's landmark FDA OTC approval for Narcan Nasal Spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country," Emergent BioSolutions CEO Robert G. Kramer said in a statement. (Hernandez, 3/29)
Bay Area News Group:
FDA Approves Narcan, But Many Barriers Remain As California Considers New Laws
“The cost barrier is still very real,” said Rachel Sussman, who practices primary care and addiction medicine at O’Connor Hospital in San Jose. “How many families are going to be able to afford this is a real problem. But I think the fact that it is now possible (to get it over-the-counter) does start to shift the conversation about who should have naloxone available, who can have it, and how easy it is to get.” (Nickerson, 3/29)
CNN:
FDA Approves First Over-The-Counter Version Of Opioid Overdose Antidote Narcan
The White House drug czar said businesses, such as restaurants and banks, and schools will be encouraged to purchase over-the-counter naloxone. “We will encourage businesses, restaurants, banks, construction sites, schools, others to think about this – think about it as a smoke alarm or a defibrillator, to make it as easily accessible, because it’s not just you. It could be your neighbor, it could be your family, your friend, a person at work or school who might need it, ” Dr. Rahul Gupta said. The nasal spray will come in a package of two 4-milligram doses, in case the person overdosing does not respond to the first dose. However, the drug’s maker, Emergent BioSolutions, says most overdoses can be reversed with a single dose. The product could be given to anyone, even children and babies. (Kounang, Christensen and McPhillips, 3/29)
The Boston Globe:
Advocates Cheer OTC Approval For Narcan, But Questions Remain About Price And Insurance
Traci C. Green, professor and director of the Opioid Policy Research Collaborative at Brandies University, was thrilled by the news. “It’s about time,” said Green. “This is the best news you could possibly hear. It wasn’t all that long ago, naloxone wasn’t even covered [by insurance]. It took a lot of advocacy to shift that.” Green envisions naloxone being sold at restaurants, highway rest stops, even vending machines. (Freyer and Mohammed, 3/29)
The New York Times:
10 Questions About Narcan
Think of Narcan or any naloxone nasal spray as a fire extinguisher, said Corey Davis, director of the Harm Reduction Legal Project at the Network for Public Health Law. “Hopefully you’ll never need it,” he said. “But at some point maybe the kitchen’s going to catch on fire and you won’t have time to run to the fire extinguisher store.” Here is some guidance for using Narcan correctly. (Hoffman, 3/29)
