naloxone multidose nasal spray (AP003) / Emergent Biosolutions - LARVOL DELTA

A Phase 1, Open-Label, Randomized Study to Investigate the Pharmacokinetics and Safety of Multiple Doses of Intranasal Naloxone in Healthy Participants. (PubMed, Clin Transl Sci) - P1 | "There was a dose-dependent increase in Cmax, AUC0-inf, pAUC, and AUC0-t; however, statistical significance for dose proportionality was not seen in AUC0-inf, AUC0-t, and Cmax. All treatment emergent adverse events were mild or moderate in severity and no serious adverse events were reported."

Journal • P1 data • PK/PD data • Addiction (Opioid and Alcohol) • CNS Disorders

Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Emergent BioSolutions | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders