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Monday, March 11, 2024

Indivior Publishes on Nasal Spray Rapid Reversal of Opioid-Induced Respiratory Depression

 

  • This head-to-head pharmacodynamic study in healthy volunteers examined the ability of both OPVEE and intranasal naloxone to reverse opioid-induced respiratory depression, which is the shallow and slow breathing associated with an opioid overdose
  • In this model, OPVEE 2.7mg reversed respiratory depression to 95% of pre-opioid baseline within 5 minutes; a similar reversal following a 4 mg dose of intranasal naloxone required 20 minutes
  • "Reversal of opioid-induced respiratory depression in healthy volunteers: comparison of intranasal nalmefene and intranasal naloxone", was published in the Journal of Clinical Pharmacology (Reversal of Opioid‐Induced Respiratory Depression in Healthy Volunteers: Comparison of Intranasal Nalmefene and Intranasal Naloxone - Ellison - The Journal of Clinical Pharmacology - Wiley Online Library) and is the first head-to-head comparison examining the effects of 2.7 mg intranasal (IN) nalmefene (OPVEE) and 4 mg IN naloxone on opioid-induced respiratory depression. This study was a part of the OPVEE development program and reviewed by the FDA as part of the approval process.

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