News Release Details
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
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
“The initiation of this head-to-head study is an important step in our comprehensive development program for OPNT003, nasal nalmefene,” said Dr.
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.
The development of OPNT003 is supported by grants from the
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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.
- 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.
- Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic. Distributed via the
CDCHealth Alert Network, December 17, 2020, CDCHAN-00438
- Volkow, N., Collins, F. The Role of Science in Addressing the Opioid Crisis. N Engl J Med. 2017. 377:391-394
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