Award Notice: Intranasal Nalmefene Drug-Device Combination

Contracting Office ZIP Code: 20024 Contracting Office Address: Constitution Center, 400 7th St SW, Washington, D.C. 20024 Contracting Officer: Jonathan Gonzalez; [email protected] Solicitation Number: 75A50123R00003 Closing Response Date: September 15, 2023 Subject: Award Notice: Indivior Inc –Intranasal Nalmefene Drug-Device Combination Contract Number: 75A50123C00068 Awarded: September 27, 2023 Contract Award Dollar Amount: $110,679,817 Line Item Number: CLIN 0001 - 0012 Contractor: Indivior Inc. Set-aside Status: N/A Description: This acquisition will allow BARDA to invest Project Bioshield funds for procurement of finished, packaged intranasal nalmefene drug‐device product held as vendor managed inventory as well as post‐approval development to support regulatory approval for intranasal nalmefene as a drug/device combination product to treat opioid overdose, including by synthetic opioids such as fentanyl, in pediatric populations; a real world effectiveness study versus naloxone; and a 3‐year stability study to support shelf‐life extension.