Breaking News - AcelRx Wins ~$3.5M US Army Medical Research Acquisition Contract For Dsuvia
5:33pm ET 7/16/2020 Benzinga
The United Stated Army Medical Research Acquisition Activity (USAMRAA), in support of the U.S. Army Medical Materiel Development Activity (USAMMDA), intends to negotiate solely (as prescribed in FAR 13.106(b)(1)(i)) with AcelRx Pharmaceuticals, Inc., 351 Galveston Drive, Redwood City, CA, 94063-4736, as the only responsible source that can provide one (1) commercial lot of 3,200 boxes of U.S. Food and Drug Administration (FDA) approved Sufentanil NanoTab brand name Dsuvia (New Drug Application (NDA)) # 209128 letter dated 12 December 2016. Dsuvia is for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. Dsuvia is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use. This acquisition is being conducted under FAR Part 12 Acquisition of Commercial Items. Provisions and clauses in effect through Federal Acquisition Circular (FAC) 2020-04, dated 15 January 2020, are incorporated.
USAMMDA, located in Fort Detrick, MD, is a subordinate activity under U.S. Army Medical Research and Development Command (USAMRDC) supporting the Command as the primary advanced development medical research, development, and acquisition organization within DOD and is responsible for meeting medical developmental requirements from both the Army and other military services. The USAMMDA is the Department of Defense's (DOD) medical product development activity for products designed to protect and preserve the lives of Warfighters. The USAMMDA develops new drugs, vaccines, devices, and medical support equipment that enhance readiness, ensures the provision of the highest quality medical care to the DOD, and maximizes survival of medical casualties on the battlefield. USAMMDA project managers guide the development of medical products for the U.S. Army Medical Department, other U.S. Services, the Joint Staff, the Defense Health Agency, and U.S. Special Forces community. The process takes promising technology from DOD, industry, and academia to U.S. Forces, from the testing required for FDA approval or licensing, to fielding and sustainment of the finished product.
USAMMDA’s, Warfighter Protection and Acute Care (WPAC) Project Management Office intends to procure firm-fixed-price contract for FDA approved brand name Dsuvia to be used to conduct a comparative clinical trial to aid clinical practice guideline development. USAMMDA has a requirement for one commercial lot of 3,200 boxes of FDA approved brand name Dsuvia, with a base and three (3) optional Contract Line Item Numbers (CLINs) to procure up to 3,000 boxes per CLIN of FDA brand name Dsuvia. The goal of the clinical trial is gain information regarding acceptability of Dsuvia compared to Oral Transmucosal Fentanyl Citrate (OTFC) in an Emergency Room (ER) setting in patients with moderate to severe pain requiring an opioid. The clinical trial contains several secondary endpoints including healthcare provider feedback. Based on the above information, the only technically acceptable product is provided by AcelRx Pharmaceuticals, Inc. The maximum estimated dollar amount for the duration of the contract is $3,525,800.00.
The intended procurement will be classified under North American Industry Classification System (NAICS) 325412 Pharmaceutical Preparation Manufacturing with a Small Business Size Standard of 1250 employees. This notice of intent is not a request for competitive proposals and no solicitation document will be posted for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
