Opiant Pharmaceuticals Announces Publication of Clinical Pharmacokinetic Data Supporting Potential of OPNT002, Nasal Naltrexone, for Treatment of Alcohol Use Disorder
"One of the most interesting findings of this clinical study was that the plasma half-life of OPNT002 is essentially identical to the overdose reversal agent naloxone,” said
The study authors concluded that, while OPNT002 may have limited potential as a treatment for opioid overdose, it is well suited for “on-demand” dosing to treat alcohol use disorder (AUD). Evidence indicates that the activation of both m and δ‐opioid receptors, resulting from alcohol releasing the brain’s endogenous opioids (endorphins), contributes to alcohol’s reinforcing and addictive properties. Effective blockade of δ‐opioid receptors requires much higher plasma naltrexone concentrations than is achieved by currently approved naltrexone products for AUD. Thus, the ability to rapidly achieve these high plasma levels in anticipation of drinking, or once drinking has started, may increase the efficacy of naltrexone for treating AUD.
“The results and insights from this study have formed the basis for an OPNT002 formulation selection study in AUD, which is slated to begin in the second quarter of 2019 followed by enrollment of patients in a Phase 2 study later this year,” said
About Alcohol Use Disorder
Alcohol use disorder is a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using. Approximately 16.3 million people in
OPNT002, nasal naltrexone, is in development for the treatment of AUD. In contrast to currently approved naltrexone formulations, OPNT002 is designed to be taken nasally on an "as needed" basis in anticipation of drinking, or once drinking has started, to reduce alcohol intake. Phase 1 data demonstrate rapid intranasal absorption of OPNT002, which confirms its suitability for targeted dosing. Opiant is seeking approval of OPNT002 under the 505(b)(2) regulatory pathway, for which the
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Source: Opiant Pharmaceuticals, Inc.