Opiant Pharmaceuticals said that it has filed the first part of a 505(b)(2) NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose and that it expects to complete the submission later this year. The company recently announced that a PD study of OPNT003 met its primary endpoint.
Opiant President and CEO Roger Crystal commented, “The opioid epidemic has evolved with the widening threat from potent synthetic opioids like fentanyl and there is significant evidence indicating that a new treatment option is needed. We believe the results from the pharmacokinetic (PK) and pharmacodynamic (PD) studies, in which OPNT003 demonstrated fast, strong, and long-lasting action and a well-tolerated safety profile, support OPNT003 as a potential new treatment option for opioid overdose. We look forward to working with the FDA to complete this rolling submission for OPNT003, nasal nalmefene, and we will provide an update when the NDA is completed.”
The FDA granted Fast Track designation for OPNT003 in November 2021, the company noted. Development of the intranasal formulation, which is delivered via Aptar Pharma’s Unit Dose System (UDS) device, is being funded in large part by the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute on Drug Abuse (NIDA).
Read the Opiant Pharmaceuticals press release.
