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The US Food and Drug Administration (FDA) today announced "unprecedented" measures to help companies develop over-the-counter naloxone to help reduce the number of drug overdose deaths. ; opioids.
"The number of overdose deaths from prescription and illegal opioids has more than doubled in the last seven years, reaching almost 48,000 in 2017, it is essential that we continue to deal with this tragedy on all the fronts, "said FDA Commissioner Scott Gottlieb in a statement.
This includes new ways to increase the availability of naloxone, which can usually counter the effects of overdose in minutes when it is administered quickly, Gottlieb said.
To prompt pharmaceutical companies to market Naloxone over-the-counter quickly, the FDA has developed two "Drug Facts" labels, one for use with Naloxone Nasal Spray and another with a naloxone auto-injector. The "friendly" instructions are simple to follow.
Companies seeking approval for an over-the-counter product are required to develop a drug presentation label and to conduct studies to demonstrate that consumers can understand how to use this product. Some companies have identified the need for these studies as an obstacle to the development of over-the-counter naloxone products.
"This is the first time that the FDA has been proactively developing and testing an LDF for a drug intended to support the development of an over-the-counter product," Gottlieb said. "We have proactively designed, tested, and validated the key labeling requirements needed to approve an over-the-counter version of naloxone and make it available to patients." One of the key components of the Availability of the OTN is now in place, "he said.
"These efforts should relaunch the development of over-the-counter naloxone products to promote broader access to this drug," Gottlieb said.
"We are taking many steps to improve the availability of naloxone products and we are committed to working with other federal, regional and local officials, health care providers, patients and communities across the country. countries to fight the heavy human and economic toll created by opioid abuse and addiction, "added Gottlieb.
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