Data published online in The Journal of Clinical Pharmacology
SANTA MONICA, Calif., April 03, 2019 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (OPNT), a specialty pharmaceutical company developing medicines for addictions and drug overdose, today announced that clinical pharmacokinetic data of OPNT002, nasal naltrexone containing Intravail® (dodecyl maltoside), were published online in The Journal of Clinical Pharmacology. The manuscript titled, Enhanced Intranasal Absorption of Naltrexone by Dodecyl Maltopyranoside: Implications for the Treatment of Opioid Overdose, reported that the addition of the absorption enhancer Intravail® to naltrexone resulted in very rapid and robust increases in plasma naltrexone concentrations compared to either an intramuscular injection or tablet.
"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 Phil Skolnick, Ph.D., D.Sc. (hon.), Chief Scientific Officer of Opiant. “This was unexpected given the longer half-life of oral naltrexone and may limit the usefulness of OPNT002 as a rescue medication, particularly against longer-lived synthetic opioids such as fentanyl that are now linked to more overdose deaths than both heroin and prescription opioids.”
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 Roger Crystal, M.D., Chief Executive Officer of Opiant. “These data also underscore Opiant’s commitment to pushing innovation and advancing our pipeline of addictions and drug overdose treatments to address some of today’s most pressing public health issues and concerns.”
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 the United States suffer from some form of AUD. According to the National Institute on Alcohol Abuse and Alcoholism, only 6.7 percent of these individuals receive treatment.
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 U.S. Food and Drug Administration has accepted a harm reduction-based primary endpoint rather than a primary endpoint based on abstinence.
Intravail® is a registered trademark of Neurelis, Inc. Intravail® drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs (up to 30,000 daltons in size) that can currently only be administered by injection. Intravail can be utilized via the oral, buccal, dermal and intranasal routes of drug administration.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing medicines for addictions and drug overdose. The National Institute on Drug Abuse, a division of the National Institutes of Health, describes addictive disorders as chronic relapsing brain diseases that burden society at both the individual and community levels. Opiant's first drug overdose product, NARCAN® Nasal Spray, is licensed to Adapt Pharmaceuticals, now owned by Emergent BioSolutions, Inc. For more information, visit www.opiant.com.
This press release contains forward-looking statements. 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, 2018 and Form 10-KT for the transition period August 1 to December 31, 2017, filed with the Securities and Exchange Commission on March 21, 2019, and March 7, 2018, respectively, including under the caption titled "Risk Factors." These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
For Media Inquiries:
Peter Duckler, W2O
For Investor Inquiries:
Dan Ferry, LifeSci Advisors, LLC