OPNT003 Nalmefene Nasal Spray
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Phase I
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Phase III
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FDA Approval
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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 2021.
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).