Nasal Nalmefene Produces Positive Results Reversing Respiratory Depression

April 28, 2022
Giuliana Grossi

The completion of this study concluded the planned clinical development program for nasal nalmefene and the company expects to file a New Drug Application in the second half of 2022.

Opiant Pharmaceuticals announced positive topline results from a head-to-head pharmacodynamic (PD) study that compared nasal nalmefene (OPNT003), to nasal naloxone. Nasal nalmefene mnalmefenenalmefeneet the primary endpoint of non-inferiority and produced a greatter reversal in remifentanil-induced respiratory depression than nasal naloxone.

Nasal nalmefenemefene is an investigationalational treatment for opioid overdose. In this crossover study, a 3 mg dose of nasal nalmefene hydrochloride was compared with a 4 mg dose of nasal naloxone hydrochloride to assess its capability of reversing the effects of an opioid overdose.

Investigators measured changes in minute ventilation after 1 of the 2 trial drugs was administered to the 50 healthy volunteers. The primary endpoint was at 5 minutes. The nalmefene increases in minute ventilation were 5.745 L/min and the naloxone increases were 3.011 L/min.

According to a preliminary analysis of the participants, nasal nalmefene produced a reversal of respiratory depression that was almost twice that produced by nasal naloxone at the 5 minute endpoint. The completion of this study concluded the planned clinical development program for nasal nalmefene and the company expects to file a New Drug Application (NDA) in the second half of 2022.

“The findings from this PD study are compelling and add to a body of non-clinical and clinical evidence demonstrating the potential of OPNT003, nasal nalmefene, to offer an important treatment option for opioid overdose,” Richard C. Dart, MD, PhD, Director, Rocky Mountain Poison & Drug Center, Denver Health and Hospital Authority, and member of Opiant’s Scientific Advisory Board, said in a statement.

“Synthetic opioids, such as fentanyl, are responsible for the great majority of overdoses today, are far more potent, have a more rapid onset, and can have a long duration of action," he continued. "They can quickly depress respiration and can continue to deprive the brain of oxygen even after administration of naloxone, the only current FDA-approved treatment for opioid overdose. Unless quickly reversed, this can cause severe hypoxic injury to the victim’s organs and brain, and potentially death.”


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