OPNT002 is a very rapid acting, intranasal formulation of naltrexone. The ability to rapidly elevate plasma naltrexone concentrations to levels higher than currently achieved by available naltrexone products will result in a more effective blockade of delta opioid receptors, thereby increasing its therapeutic effects compared to oral or injectable naltrexone.

Because Phase 1 clinical data with OPNT002 demonstrated rapid intranasal absorption and a short duration of action compared to currently available products, OPNT002 can be taken intranasally on an ‘as needed’ (targeted) basis to moderate alcohol intake when the patient anticipates drinking or is in a “high risk” situation (e.g., at a party or restaurant).  Following completion of a formulation selection study later this year, the company will begin a double blind, placebo controlled Phase II study in patients diagnosed with an AUD.  Reductions in heavy drinking, rather than abstinence, is the goal of pharmacotherapy with OPNT002.

Disease Area

Alcohol Use Disorder

PreclinicalPhase IPhase IIPhase IIINDAFDA Approval
Preclinical
Phase I
Phase II
Phase III
NDA
FDA Approval