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Opiant Pharmaceuticals Releases Positive Topline Results From Study of New Opioid Overdose Reversal Treatment
Opiant Pharmaceuticals, the developer of Narcan (naloxone) nasal spray, has announced positive topline results from a study of a new investigational treatment for opioid overdose.
The ability of a 3-mg dose of Opiant’s nasal nalmefene, known as OPNT003, to reverse respiratory depression produced by the synthetic opioid remifentanil was compared with the reversal effect of a 4-mg dose of nasal naloxone. A preliminary analysis of 50 health volunteer study subjects found that treatment with OPNT003 produced a reversal of respiratory depression nearly twice that produced nasal naloxone at a primary endpoint of 5 minutes.
In a news release announcing the findings, Richard C Dart, MD, PhD, Rocky Mountain Poison & Drug Center, Denver Health and Hospital Authority, and a member of Opiant’s scientific advisory board, said that the findings “add to a body of non-clinical and clinical evidence demonstrating the potential” of the investigational treatment as a viable option for reversing opioid overdose.
“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,” Dart said. “They can quickly depress respiration and can continue to deprive the brain of oxygen even after administration of naloxone, the only current [Food and Drug Administration]-approved treatment for opioid overdose. Unless quickly reversed, this can cause severe hypoxic injury to the victim’s organs and brain, and potentially death.”
The Food and Drug Administration granted fast track designation for OPNT003 in November 2021. With the completion of its pharmacodynamic study for OPNT003, the company has concluded its planned clinical development program for the medication and said it expects to complete a new drug application filing in the second half of 2022.
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