News Release Details
Opiant Pharmaceuticals Announces Completion of Enrollment in Phase 2 Clinical Trial of OPNT002, Nasal Naltrexone, in Patients with Alcohol Use Disorder
"We are pleased to have completed patient enrollment ahead of schedule and are looking forward to concluding the treatment phase of this study and releasing top-line data next year,” said
Opiant launched its Phase 2 clinical study of OPNT002 for the treatment of alcohol use disorder in
Clinical and preclinical studies have shown that alcohol releases endorphins, which are the brain’s endogenous opioids. These endorphins are thought to activate opioid receptors, which contribute to alcohol’s reinforcing and addictive properties. Current naltrexone treatments work to block mu-opioid receptors when administered orally or through injection. However, converging lines of evidence indicate that activation of delta-opioid receptors also contributes to the reinforcing properties of alcohol. The effective blockade of delta‐opioid receptors requires much higher plasma naltrexone concentrations than is achieved by currently approved naltrexone products1.
Opiant is developing OPNT002 to rapidly increase plasma concentrations of naltrexone following dosing and thereby block mu and delta-opioid receptors. In previous research, OPNT002 has demonstrated rapid nasal absorption, delivering high levels of naltrexone yet with a short half-life. Results from Phase 1 studies demonstrate that OPNT002 produces maximum plasma concentrations that are approximately 50% higher than orally administered naltrexone. This feature, along with a very rapid onset and a short plasma half-life, are characteristics ideally suited to developing OPNT002 for ‘as needed’ nasal dosing in anticipation of drinking, or once drinking has started2,3.
About Alcohol Use Disorder
Alcohol use disorder is a chronic relapsing brain disease characterized by compulsive use of alcohol and the inability to control intake. It is the third leading preventable cause of death in the
About Opiant Pharmaceuticals, Inc.
This press release contains forward-looking statements, including the anticipated results of the Phase 2 study in 2023. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "projects," "potential," or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2021, and our Form 10-Q for the quarters ended
For Media and Investor Inquiries:
1. Weerts E, Kim Y, Wand G, et al. Differences in δ and μ opioid receptor blockade measured by positron emission tomography in naltrexone-treated recently abstinent alcohol-dependent subjects. Neuropsychopharm. 2008;33:653-665. https://www.nature.com/articles/1301440
2. Krieter P, et al. Enhanced Intranasal Absorption of Naltrexone by Dodecyl Maltopyranoside: Implications for the Treatment of Opioid Overdose. Journal of Clinical Pharmacology, 2019 https://www.opiant.com/wp-content/uploads/2019/05/2019-IN-NTX-J-Clin-Pharm-1.pdf
3. Research & Development Meeting on Emerging Therapeutics for the Treatment of Addiction and Drug Overdose. Available at: https://ir.opiant.com/events/event-details/research-development-meeting-emerging-therapeutics-treatment-addiction-and
5. World Health Organization. Available at: https://www.who.int/health-topics/alcohol#tab=tab_1
6. Spencer, M et al. Rates of Alcohol-induced Deaths Among Adults Aged 25 and Over in Urban and Rural Areas: United States, 2000–2018, NCHS Data Brief No. 383, October 2020
7. Grant BF, Goldstein RB, Saha TD, Chou SP, Jung J, Zhang H, Pickering RP, Ruan WJ, Smith SM, Huang B, Hasin DS. Epidemiology of DSM-5 Alcohol Use Disorder: Results From the
Source: Opiant Pharmaceuticals