The Food and Drug Administration on Wednesday approved sales with no prescription of the nasal spray Narcan to reverse opioid overdoses, a choice that guarantees to significantly expand access to the lifesaving treatment.
The FDA’s decision means people will have the option to purchase the 4 milligram nasal spray in supermarkets, convenience stores, gas stations, vending machines and online. Emergent BioSolutions, the manufacturer, has said Narcan needs to be available with no prescription by late summer.
FDA Commissioner Dr. Robert Califf, in an announcement, said the agency is encouraging the corporate to make the nasal spray available as soon as possible at an inexpensive price.
Narcan reverses fatal overdoses by blocking the effect that opioids have on the nervous system. The nasal spray should be administered as soon as an overdose is suspected.
Two nasal spray devices typically are available in a single package. The primary dose needs to be administered in a single nostril of the person suffering an overdose after which 911 needs to be called, based on the instructions. If the person remains to be unresponsive after two to 3 minutes, the second dose needs to be administered.
After the FDA’s decision, Walgreens said it’ll offer over-the-counter Narcan later this yr in-store and online nationwide.
“Delivering access to this lifesaving medication that may reverse the consequences of an overdose if administered in time is imperative and Walgreens is already working with suppliers to bring this OTC medication to shelves,” said Zoe Krey, a Walgreens spokesperson.
Join CNBC’s Healthy Returns on March twenty ninth, where we’ll convene a virtual gathering of CEOs, scientists, investors and innovators within the health care space to reflect on the progress made today to reinvent the longer term of medication. Plus, we’ll have an exclusive rundown of the very best investment opportunities in biopharma, health-tech and managed care. Learn more and register today: http://bit.ly/3DUNbRo
The FDA said in November it was considering approving naloxone products, the generic name for medications that reverse opioid overdoses, to be used with no prescription. The push to make naloxone easier to access is a component of the agency’s efforts to fight the opioid crisis.
The Trump administration first declared the opioid epidemic a public health emergency in 2017. The Biden administration has renewed the general public health emergency every 90 days.
Greater than 564,000 people died from opioid overdoses between 1999 and 2020, based on the Centers for Disease Control and Prevention. The primary wave of the epidemic began within the Nineteen Nineties with prescription opioids, followed by a rise in deaths from heroin starting in 2010.
Deaths from synthetic opioids comparable to fentanyl have increased significantly since 2013. Greater than 71,000 people died from synthetic opioids in 2021, a 18% increase over the yr prior, based on CDC estimates.