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

We have responded to this call, and are developing 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), nasal nalmefene appeared to have a more rapid onset and longer duration of action compared to naloxone. Based on discussions with the Food and Drug Administration, we will conduct a larger confirmatory study later this year, and intend to file a New Drug Application (NDA) for this product in 2020.

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).

Disease Area

Opioid Overdose

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