
The U.S. Food and Drug Administration on Wednesday approved the over-the-counter use of a nasal spray that can reverse an opioid overdose. Research has shown that wider availability of naloxone (Narcan) could save lives as the opioid epidemic rages on in this country. “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 Dr. Robert Califf said in an agency news release. “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,” Califf said. “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.” Emergent BioSolutions, the Maryland company that makes the Narcan spray, made no mention of price in a statement it released after the FDA approval was announced, but the company’s president applauded the move. The approval “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,”… read on > read on >