This Nasal Spray Rapidly Reverses Effects Of Fentanyl Overdose And No, It's Not Naloxone

Indivior PLC INDV announced the results from a pharmacodynamic study on Monday demonstrating that OPVEE rapidly reverses opioid-induced respiratory depression, the major cause of death due to opioid overdose.

The Study

Titled “Reversal of opioid-induced respiratory depression in healthy volunteers: comparison of intranasal nalmefene and intranasal naloxone”, the study was published in the Journal of Clinical Pharmacology. It was part of the OPVEE development program and reviewed by the FDA as part of the approval process.

The research focused on a head-to-head comparison examining the effects of 2.7 mg intranasal (IN) nalmefene (OPVEE) and 4 mg IN naloxone on opioid-induced respiratory depression.

The findings showed that OPVEE reversed the respiratory depression produced by remifentanil – which is a synthetic opioid related to fentanyl – during the first 5 minutes following the administration.

The subjects’ minute ventilation – the volume of air inhaled or exhaled from a person’s lungs per minute – reached roughly 95% of the pre-opioid baseline within 5 minutes following the administration of OPVEE 2.7mg, while maintaining reversal through the initial 20-minute monitoring period.

The 4 mg dose of intranasal naloxone required 20 minutes to restore respiration to levels equaling those observed 5 minutes after OPVEE, the researchers said, adding the point estimates favored OPVEE, demonstrating non-inferiority and superiority to naloxone.

See also: Life-Saving Overdose Reversal Naloxone In Schools: MN’s Proposal To Combat Opioid Epidemic

Why It Matters

"While both reverse the effects of remifentanil-induced respiratory depression, this pharmacodynamic study provides important insights about the time course of reversal for both drugs,” Christian Heidbreder, Ph.D. and chief scientific officer of Indivior, said. “The first few minutes following an overdose – particularly with very potent and fast-acting synthetic opioids like fentanyl – are critical for a successful rescue. OPVEE reverses the respiratory depression rapidly in this model, making it a valuable tool for combating the synthetic opioid overdose crisis we’re facing as a nation.”

Fentanyl is widespread in the illicit drug supply and more common than heroin, according to the Substance Abuse and Mental Health Services Administration.

Overdose deaths are at historically high levels nationwide with over 108,000 people dying from overdose in 2022, as per data released by the Centers for Disease Control and Prevention (CDC).

The rapid-acting reversal agents such OPVEE and IN naloxone can help alleviate the effects of synthetic opioids, like fentanyl, on the human body such as impaired breathing and reduction of oxygen levels to vital organs like the brain.

Narcan, the prescription nasal spray that reverses opioid overdoses has been available over the counter (OTC), for months, following the approval from the U.S. Food and Drug Administration (FDA).

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