What is the role of naloxone in the management of opioid overdose?

Updated: Jun 21, 2018
  • Author: David W Dixon, DO; Chief Editor: Glen L Xiong, MD  more...
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Answer

In November 2015, intranasal naloxone was approved by the FDA after fast track designation and priority review. It is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The ready-to-use single-dose sprayer delivers a 4-mg dose by intranasal administration. Approval was based on pharmacokinetic studies that compared IM and intranasal dosage forms. The National Institute on Drug Abuse also was crucial to the approval by forming a public-private partnership by designing and conducting the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. [29, 30]

In April 2014, the FDA approved naloxone (Evzio) as an autoinjector dosage form for home use by family members or caregivers. The product delivers 0.4 mg that may be administered either IM or SC in the anterolateral aspect of the thigh. The device includes visual and voice instruction, including directions to seek emergency medical care immediately after use. [31, 32]

In 1996, community-based programs began offering naloxone and other opioid overdose prevention services to persons who abuse opioids, their families, and friends, and service providers (eg, homeless shelters). Since their inception, the programs have distributed naloxone to over 53,000 persons who abuse drugs. Naloxone is effective in treating acute overdose and is first-line treatment. [33]


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