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Preliminary findings show safety of intranasal OPNT002 for alcohol addiction

Opiant Pharmaceuticals Inc. recently announced phase 1 data showing efficacy and safety of OPNT002, intended for treatment of alcohol use disorder, among healthy individuals.

“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,” Phil Skolnick, PhD, DSc, chief scientific officer at Opiant Pharmaceuticals Inc., said in a press release. “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 [alcohol use disorder].”

OPNT002 is an intranasally dosed formulation of naltrexone.

To assess the effects of Intravail on pharmacokinetic properties of OPNT002 and safety of OPNT002, researchers conducted an inpatient, open-label, four-period, four-treatment, one-sequence crossover design study among 14 healthy volunteers aged 18 to 55 years with no preexisting nasal abnormalities. Study participants received four naltrexone treatments during four dosing periods.

When OPNT002 included Intravail, the maximum plasma concentration increased threefold, while the median time to reach the maximum observed plasma concentration decreased from 30 minutes to 10 minutes.

OPNT002 administered with Intravail had a faster median time to reach maximum observed plasma concentration compared with IV injection.

Naltrexone absorption after oral administration of 50 mg was slower than intranasal and IV administration at previous time points.

Researchers found no severe or serious adverse events.

“Naltrexone is a well-known treatment for [alcohol use disorder], and this study sheds new light on the potential clinical benefits of combining intranasally administered naltrexone with Intravail,” Stephanie Samples O’Malley, PhD, of Yale School of Medicine, said in a press release. “Although the sample size of this study is small, these data suggest that pairing Intravail with [intranasal] naltrexone enhances the effect of the drug which could support the development of a new method for treating [alcohol use disorder].”

Opiant recently signed a contract manufacturing agreement with Renaissance to begin optimizing an intranasal naltrexone formulation for phase 2 studies.