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- W2554523542 abstract "A panel of advisers recently offered a mixed message to FDA about whether new naloxone products should deliver a greater amount of drug per dose than current formulations. The nationwide epidemic of opioid overdose deaths formed the backdrop for the October 5 joint meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee in Silver Spring, Maryland. The specific focus of the meeting was naloxone products intended for administration by laypersons in community settings who witness an overdose. “Naloxone saves lives,” said FDA Medical Officer Jennifer Nadel. Currently, two naloxone products—Kaléo Inc.’s Evzio autoinjector and Adapt Pharma’s Narcan Nasal Spray—are labeled for emergency use in community settings and come with instructions for administration by laypersons who witness an opioid overdose. The Evzio formulation that was approved in 2014 delivers a 0.4-mg subcutaneous or intramuscular dose of naloxone, and Narcan Nasal Spray, which was approved last year, delivers a 4-mg intranasal dose of the opioid antagonist." @default.
- W2554523542 created "2016-11-30" @default.
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- W2554523542 date "2016-12-01" @default.
- W2554523542 modified "2023-10-16" @default.
- W2554523542 title "Experts weigh minimum naloxone dose as opioid crisis evolves" @default.
- W2554523542 doi "https://doi.org/10.2146/news160067" @default.
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