The FDA has accepted the NDA for nasal nalmefene, OPNT003, to treat opioid overdose.
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Opiant Pharmaceuticals’ nasal nalmefene, OPNT003, for the treatment of opioid overdose.1
The 505(b)2 NDA submission for OPNT003 is supported by results from 3 studies: (1) a pharmacokinetic study comparing OPNT003 with an intramuscular nalmefene injection2; (2) a PK study comparing a single intranasal dose with a single dose in each nostril or 2 doses in a single nostril3; and (3) a pharmacodynamic study comparing nasal nalmefene to naloxone HCI (Narcan) nasal spray 4 mg in a clinical model of opioid induced respiratory depression.4
“We are delighted to announce that the FDA has accepted Opiant’s NDA for OPNT003 for filing and designated it priority review status,” said Roger Crystal, MD, President and CEO of Opiant. “We believe the data supporting this NDA indicates that OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis. We look forward to working with the FDA during the review process.”
The NDA was granted Priority Review designation and a Prescription Drug User Fee Act action date of May 22, 2023.
1. Opiant Pharmaceuticals announces FDA acceptance and priority review of NDA for OPNT003, nasal nalmefene, for opioid overdose. Opiant. News release. January 19, 2023. Accessed January 20, 2023. https://ir.opiant.com/news-releases/news-release-details/opiant-pharmaceuticals-announces-fda-acceptance-and-priority
2. Pharmacokinetic evaluation of intranasal nalmefene. (NCT04759768). ClinicalTrials.gov. Updated October 22, 2021. Accessed January 20, 2023. https://beta.clinicaltrials.gov/study/NCT04759768
3. Pharmacokinetic evaluation of intranasal nalmefene using three dosing regimens. (NCT05219669). ClinicalTrials.gov. Updated December 12, 2022. Accessed January 20, 2023. https://beta.clinicaltrials.gov/study/NCT05219669
4. Pharmacodynamic evaluation of intranasal nalmefene. (NCT04828005). ClinicalTrials.gov. Updated December 9, 2022. Accessed January 20, 2023. https://beta.clinicaltrials.gov/study/NCT04828005