Opiant beats path to FDA after nasal overdose drug matches Narcan

Opiant Pharmaceuticals’ opioid overdose drug candidate has held its own against nasal naloxone in a trial of healthy volunteers, giving the company the data it needs to file for approval in the second half of the year.

The candidate, OPNT003, is a nasal formulation of nalmefene. The FDA approved an injectable form of the molecule in the 1990s, but that product was removed from the market in 2008. Opiant decided to try to resurrect the molecule in a nasal delivery format in the belief its half-life and affinity for opiate receptors may make it better than naloxone at treating overdoses on synthetic opioids such as fentanyl.

Opiant has built out the evidence on OPNT003 over the past year, culminating in the release of data from a crossover clinical trial that compared 3 mg of nasal nalmefene with 4 mg of nasal naloxone in healthy volunteers. The study assessed the ability of the interventions to reverse respiratory depression caused by remifentanil, a synthetic opioid.

After the opioid-induced low, recipients of nalmefene had a 5.745 L/min change in minute ventilation, a measurement of the amount of air that enters the lungs per minute. The change in the control group was 3.011 L/min, causing the study to conclude that nalmefene is non-inferior to naloxone.

“These data, taken together with our prior PK studies, suggest that OPNT003 could be well suited to address the challenges in treating today’s opioid overdoses, which are driven by synthetic opioids, like fentanyl. We look forward to continuing to work towards submitting our new drug application, which we anticipate occurring in the second half of this year,” Opiant CEO Roger Crystal said in a statement.