The US Food and Drug Administration (FDA) announced "unprecedented" steps to support companies in developing over-the-counter (OTC) naloxone to help reduce opioid overdose deaths."With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last 7 years to nearly 48,000 in 2017, it's critical that we continue to address this tragedy from all fronts," FDA Commissioner Scott Gottlieb, MD, said in a statement.
This includes new ways to increase availability of naloxone, which typically can counter the overdose effects within minutes when administered quickly, said Gottlieb. To encourage drug companies to quickly bring OTC naloxone to the market, the FDA developed two model "drug facts" labels — one for use with naloxone nasal spray and the other for use with a naloxone auto-injector — and conducted extensive testing to ensure the "consumer-friendly" instructions are simple to follow.
Naloxone is used to block the effects of opioids overdose
Naloxone, sold under the brandname Narcan among others, is a medication used to block the effects of opioids, especially in overdose. Naloxone may be combined with an opioid (in the same pill) to decrease the risk of opioid misuse. When given intravenously, naloxone works within two minutes, and when injected into a muscle, it works within five minutes; it may also be sprayed into the nose.
The effects of naloxone last about half an hour to an hour. Multiple doses may be required, as the duration of action of most opioids is greater than that of naloxoneThis includes new ways to increase availability of naloxone. Companies seeking approval of an OTC product are required to develop a drug facts label (DFL) and conduct studies to demonstrate that consumers can understand how to use the product. Some companies have identified the requirement to perform these studies as a barrier to development of OTC naloxone products.
"This is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product," said Gottlieb. "We proactively designed, tested, and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients. One of the key components for OTC availability is now in place," he noted.
"These efforts should jump-start the development of OTC naloxone products to promote wider access to this medicine," said Gottlieb."We're taking many steps to improve availability of naloxone products and we're committed to working with other federal, state, and local officials; healthcare providers; patients; and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction," added Gottlieb.