Disease Area

Opioid Overdose

PreclinicalPhase IPhase IIPhase IIINDAFDA ApprovalPartner
Preclinical
Phase I
Phase II
Phase III
NDA
FDA Approval

Prompted by an upsurge in opioid overdose deaths driven by synthetic opioids, the National Institutes of Health (NIH) leadership recently called for the development of “…stronger, longer-acting formulations of antagonists.”

Recent provisional CDC data indicated in the past year ending November 2021, over 80,000 people died from opioid overdose, including more than 150 deaths every day linked to synthetic opioids, particularly fentanyl.

We have responded to this call, and are developing OPNT003, an intranasal formulation of nalmefene, a more potent, longer acting opioid antagonist that is especially well-suited to treat overdose caused by synthetics.

In a pilot clinical study conducted in collaboration with the National Institute on Drug Abuse (NIDA), OPNT003, nasal nalmefene, appeared to have a more rapid onset and longer duration of action compared to naloxone.

Data from a larger confirmatory pharmacokinetic (PK) study for OPNT003 demonstrated rapid absorption and higher plasma concentrations versus an intramuscular injection (p<0.0001), confirming the findings of our initial pilot PK study.

Data from a head-to-head pharmacodynamic (PD) study comparing OPNT003, to Nasal Naloxone, demonstrated positive topline results in reversing respiratory depression produced by remifentanil, a synthetic opioid. The two study drugs were assessed by measuring changes in minute ventilation following administration of the respective study drug, with the primary endpoint at five minutes post administration.

The U.S. Food and Drug Administration granted Fast Track Designation for OPNT003 in November 2021. We expect to complete an NDA filing in the second half of 2022.

This program is fully funded through NDA filing by a grant from the NIDA, an institute of the NIH and a contract from the Biological Advanced Research and Development Agency (BARDA).