(ReclaimingAmerica.net) – The US Food and Drug Administration has approved the over-the-counter use of the opioid overdose reversal drug Narcan, making it the first medication of its kind to be sold without a prescription throughout the United States.
The FDA approval of the Emergent BioSolutions Inc. naloxone-based nasal spray comes against the backdrop of record levels of drug overdose deaths in the US.
In 2021, there were almost 107,000 overdose deaths in America, as per data from the National Institutes of Health, an increase of about 15% compared with 2020.
The newly approved OTC use of Narcan will boost the life-saving drug’s availability while aligning the federal policies with those of states offering the medication without prescription through a pharmacist, Newsmax reported.
Naloxone quickly reverses or blocks the effects of opioids and restores normal breathing. It’s most effective if administered in the first minutes after signs of an overdose appear.
The decision of the FDA in favor of Narcan’s OTC use follows a unanimous recommendation to that end issued in February by an independent panel of advisers.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Robert Califf declared in a statement.
“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,” he elaborated.
“We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” Califf added.
Dr. Rahul Gupta, director of the Office of National Drug Control Policy at the White House, said businesses operating public venues, such as banks and restaurants, will be encouraged to buy Narcan.
He emphasized that the key to ensuring that the naloxone nasal spray saves lives would be making it widely accessible.
“It’s really important that we continue to do everything possible in our power to make this life-saving drug available to anyone and everyone across the country,” Gupta declared, as cited by
Narcan’s Maryland-based producer, Emergent BioSolutions, said on Wednesday that the nasal spray would become available in stores and online by the end of the summer. The FDA approval of its medication caused the company shares to rise by 5.5%.
The Narcan nasal spray will come in a package of two 4-milligram doses. According to the drug maker, a single dose is enough to reverse most overdoses.
However, the second one is included in the package in case the overdosing person doesn’t respond to the first one.
The U.S. Food and Drug Administration on Wednesday approved the over-the-counter use of Emergent BioSolutions Inc's Narcan, making it the first opioid overdose reversal drug to be sold nationwide without a prescription. https://t.co/D6KQtgE2PT
— NEWSMAX (@NEWSMAX) March 29, 2023