Opiant Pharmaceuticals Announces First Subjects Dosed in Study Comparing OPNT003, Nasal Nalmefene, With Nasal Naloxone

Rhea-AI Summary

Opiant Pharmaceuticals (NASDAQ: OPNT) has initiated a pharmacodynamic study comparing its nasal nalmefene (OPNT003) with nasal naloxone for reversing remifentanil-induced respiratory depression. This randomized clinical trial is timely, as opioid overdose deaths have surged, reaching over 63,000 in 2020. Top-line data from the study is anticipated in Q4 2021. Notably, nalmefene is reported to be five times more potent than naloxone, with a longer half-life, offering potential advantages in treating overdoses. The trial's goal is to support OPNT003's therapeutic benefits amid rising opioid overdose incidents.

Positive

• Initiation of a head-to-head clinical study for OPNT003 with potential to provide greater efficacy in overdose treatments.
• Expected top-line data in Q4 2021 could bolster investor confidence and market position.
• Nalmefene's potency reported as five-fold higher than naloxone, potentially enhancing treatment effectiveness.
• Longer half-life of nalmefene (up to eight hours) may reduce the risk of renarcotization, improving patient outcomes.

Negative

• None.

• Pharmacodynamic study will compare OPNT003, nasal nalmefene, with nasal naloxone in reversing the respiratory depression produced by the synthetic opioid, remifentanil
  
  
• Top-line data expected in the fourth quarter
  
  
• This trial starts at a time when deaths resulting from opioid overdose are at record highs
  

SANTA MONICA, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today announced that the first subjects were dosed in a head-to-head clinical study comparing the effectiveness of its investigational opioid antagonist OPNT003, nasal nalmefene, with nasal naloxone.

The single-center, randomized, open-label study in heathy volunteers will evaluate the effectiveness of 3mg nasal nalmefene, in comparison to 4 mg nasal naloxone, to reverse the respiratory depression produced by the synthetic opioid, remifentanil. Details of this clinical trial can be found listed on www.clinicaltrials.gov. Identifier: NCT04828005. An overdose can be fatal when an opioid interrupts the body’s natural drive to breathe. Top-line data from the trial are expected in the fourth quarter 2021.

According to provisional data from the Centers for Disease Control and Prevention (CDC), more than 63,000 opioid overdose deaths were recorded in the United States during the 12 months ending August 2020 – a 31% increase to the prior year and record high¹. The most common are overdoses from synthetic opioids, such as illicitly manufactured fentanyl, which is 50x more potent than heroin.

“The initiation of this head-to-head study is an important step in our comprehensive development program for OPNT003, nasal nalmefene,” said Dr. Roger Crystal, President and CEO, Opiant Pharmaceuticals. “The potential for a faster acting, longer duration antagonist holds promise in the fight against an increasing number of opioid overdoses that have been driven by more powerful synthetic opioids, such as fentanyl. By directly comparing OPNT003 to nasal naloxone, we hope to generate additional data to support the potential therapeutic benefits of OPNT003, nasal nalmefene.”

Multiple studies have demonstrated nalmefene’s potency to be more than five-fold higher than naloxone at mu opioid receptors. Moreover, its reported plasma half-life is up to eight hours, which is significantly longer than naloxone’s half-life of less than two hours. This longer duration potentially reduces the likelihood of renarcotization, which can occur when a victim has taken a long-acting opioid like fentanyl, which has a half-life of seven to eight hours².

In December 2020, the CDC issued a Health Alert Network Advisory warning of substantial increases in drug overdose deaths across the U.S. driven primarily by increases in deaths involving synthetic opioids. Based on the potency of synthetic opioids, the CDC advised healthcare providers to counsel patients that multiple doses of naloxone may be needed for a single overdose event³. The leadership of the National Institute of Health (NIH) has highlighted the need for stronger, longer-acting formulations of antagonists to help prevent overdose deaths⁴.

The development of OPNT003 is supported by grants from the National Institute on Drug Abuse, part of the National Institutes of Health, and the Biological Advance Research and Development Agency.

About Opiant Pharmaceuticals, Inc. 
Opiant Pharmaceuticals, Inc., the company that developed NARCAN^® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.
For more information visit: www.opiant.com.

Forward-Looking Statements
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, 2020, filed with the Securities and Exchange Commission on March 4, 2021, 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.

References

1. Centers for Disease Control and Prevention. Provisional Drug Overdose Death Counts. March 8 , 2021. Retrieved from https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
2. Ahonen J, Olkkola, K, Hynynen M, et al. Comparison of alfentanil, fentanyl, and sufentanil for total intravenous anesthesia with Propofol in patients undergoing coronary artery bypass surgery. Brit J Anaesth 2000;85:533-540.
3. Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic. Distributed via the CDC Health Alert Network, December 17, 2020, CDCHAN-00438
4. Volkow, N.,  Collins, F. The Role of Science in Addressing the Opioid Crisis. N Engl J Med. 2017. 377:391-394

For Media and Investor Inquiries:
Ben Atkins, Opiant
(310) 598-5410
batkins@opiant.com

FAQ

What is the purpose of the pharmacodynamic study involving OPNT003?

The study aims to compare the effectiveness of OPNT003 (nasal nalmefene) with nasal naloxone in reversing respiratory depression caused by the synthetic opioid remifentanil.

When are the top-line data results expected for the OPNT003 study?

Top-line data from the OPNT003 clinical trial is anticipated in the fourth quarter of 2021.

How potent is nalmefene compared to naloxone in treating opioid overdoses?

Nalmefene is reported to be more than five-fold more potent than naloxone at mu opioid receptors.

Why is the study of OPNT003 timely in relation to opioid overdoses?

The study is timely due to record-high opioid overdose deaths, exceeding 63,000 in the year leading up to August 2020, driven primarily by synthetic opioids.

What are the potential benefits of OPNT003 over naloxone?

OPNT003's longer half-life (up to eight hours) may lead to a lower likelihood of renarcotization, providing a strategic advantage in overdose situations.