According to Opiant Pharmaceuticals, the submission of its NDA for OPNT003 nalmefene nasal spray for the treatment of opioid overdose has been completed, and the FDA’s decision on acceptance of the application is expected in February 2023. The company announced that it had initiated the rolling NDA submission at the beginning of June 2022.
Aptar Pharma’s Unit Dose System (UDS) device is used for delivery of the intranasal nalmefene, and Opiant announced earlier this year that it would invest €2 million in expanded manufacturing of the UDS device. Development of OPNT003 has been supported by funding from the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute on Drug Abuse.
Opiant CEO Roger Crystal commented, “We are very pleased to submit our NDA for OPNT003. We believe the data supporting this NDA indicate OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis in the United States.”
Opiant recently agreed to be acquired by Indivior.
Read the Opiant Pharmaceuticals press release.
