Opiant Pharmaceuticals has announced results from a Phase 1 trial of OPNT002 intranasal naltrexone, which it is developing for the treatment of alcohol use disorder (AUD). According to the company, which recently announced that it had licensed Aegis Therapeutics’ Intravail absorption enhancers for use with its opioid antagonists, the addition of Intravail to intranasal naltrexone resulted in significant differences in both Cmax and Tmax.
The study, which enrolled 14 healthy volunteers, demonstrated a decrease in the time to reach Tmax from 30 minutes to 10 minutes and a 3-fold increase in Cmax for an intranasal Intravail formulation of naltrexone versus an intranasal formulation of naltrexone alone. None of the subjects experienced any nasal irritation. Absorption of intranasal naltrexone was also faster than either intramuscular or oral administration.
Opiant Chief Scientific Officer Phil Skolnick commented, “We are very excited by the observed changes in the pharmacokinetic properties of intranasal naltrexone when combined with Intravail, particularly the ability of Intravail to reduce the time needed to reach maximum plasma concentrations, which implies a more rapid onset of action. Although additional clinical work is required, the ability to rapidly deliver an intranasal dose of naltrexone on an ‘as needed’ basis has the potential to offer patients a much-needed innovation in the treatment of AUD.”
The company also said that it has signed an agreement with Renaissance, which owns CDMO DPT Labs, for development of an Intranasal formulation for Phase 2 studies.
Read the Opiant press release.
