Award Notice: Intranasal Nalmefene Drug-Device Combination
Award Notice Posted
- Solicitation number
- 75A50123C00068
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Awarded
- to Indivior Inc.
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50123C00068 Federal contract award
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services awarded a $110,679,817 contract to Indivior Inc. to procure an intranasal nalmefene drug-device combination product for opioid overdose treatment in pediatric populations. The contract also provides for post-approval development activities to support regulatory approval of the product, a real-world effectiveness study versus naloxone, and a 3-year stability study to extend the product's shelf life. The award was issued by the Office of the Assistant Secretary for Preparedness and Response.
Notice text
Contracting Office ZIP Code: 20024
Contracting Office Address: Constitution Center, 400 7th St SW, Washington, D.C. 20024
Contracting Officer: Jonathan Gonzalez; jonathan.gonzalez@hhs.gov
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.
Awarded contract 75A50123C00068 to Indivior Inc. for 110679816.00 on 2023-09-27.
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Award Notice | |
| RFP - Intranasal Nalmefene Drug-Device Combination | Solicitation | |
| Pre-Solicitation Notice: Intranasal Nalmefene Drug-Device Combination | Pre-Solicitation | |
| Request for Information - Project NextGen: Potential Market Shaping Strategies for Vaccine Development | Special Notice |
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