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

• 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.”