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 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).