Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or
intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been
used successfully for this purpose as reported in clinical observational studies and a
randomized controlled trial. Most of the published clinical studies concerning IN
administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer
device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using
these kits is not available in the published literature. This study is designed to determine
the PK of naloxone following one and two IN administrations using the improvised kits
compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg
administered IM using the Evzio autoinjector.
Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector
Completed
Pfizer
Phase 1
2020-10-06
To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg
autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe
dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose)
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