Drug & Device News

On Nov. 18, 2015, the U.S. Food and Drug Administration (FDA) approved the use of a nasal spray version of naloxone hydrochloride to deliver life-saving medication to those experiencing an opioid drug overdose. It is the first FDA-approved nasal spray of its kind, and will hopefully reduce the number of deaths and injuries caused by overdoses of legal opioids like hydrocodone, morphine and oxycodone, and the illegal drug heroin. These substances can so depress a victim's breathing that it becomes shallow, or may stop altogether. In the agency's press release announcing the approval, acting FDA commissioner Stephen Ostroff, M.D., said, “Combating the opioid abuse epidemic is a top priority for the FDA. We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.” See FDA press release, “FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose,” at http://1.usa.gov/1RnclcR.