REDWOOD CITY, Calif., Oct. 12, 2018 /PRNewswire/ — AcelRx Pharmaceuticals, Inc. (AcelRx) ACRX, 3.31% a specialty biologic aggregation focused on avant-garde therapies for use in medically supervised settings, appear today that the Anesthetic and Analgesic Biologic Articles Advisory Committee of the U.S. Food and Biologic Administering (FDA) voted 10-3 in favor of advising the approval of DSUVIA™ for the administering of moderate-to-severe astute affliction in medically supervised settings for developed patients. Developed to abode challenges with absolute analysis options and to accommodate an easy-to-administer dosage anatomy for accelerated abatement as aboriginal as 15 minutes, DSUVIA is a 30 mcg sufentanil book in a pre-filled applicator for sublingual administering by a healthcare professional.
“We are admiring with the Advisory Committee’s advocacy to accept DSUVIA as a analysis in medically supervised settings for adults experiencing moderate-to-severe astute pain,” said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer of AcelRx. “We attending advanced to connected accord with the FDA on the appliance as we accept DSUVIA represents an important non-invasive astute affliction administering advantage with abeyant to decidedly advance the accepted accepted of care.”
The aggregation presented DSUVIA adeptness and assurance abstracts from two randomized, placebo-controlled studies with a absolute of 261 patients and two open-label, single-arm studies with a absolute of 216 patients. In these analytic trials, DSUVIA was apparent to be well-tolerated and accustomed adeptness beyond a ambit of accommodating ages and BMIs as a non-invasive analgesic for the administering of moderate-to-severe astute pain.
The Anesthetic and Analgesic Biologic Articles Advisory Committee is convened aloft the appeal of the FDA to analysis and appraise assurance and adeptness abstracts of marketed and investigational animal biologic articles for use in anesthesiology and surgery, and makes adapted recommendations to the Commissioner of Food and Drugs. While the FDA is not apprenticed by the committee’s recommendation, it does booty its admonition into consideration. The Prescription Biologic User Fee Act (PDUFA) date for DSUVIA is November 3, 2018.
“The availability of a single-dose, non-invasive opioid, like DSUVIA, could decidedly advance my adeptness to effectively, calmly and cautiously allay astute affliction accomplished by my patients,” said David Leiman, M.D., Analytic Assistant Professor of Surgery, University of Texas at Houston, and Director, HD Analysis Corp. “It is my achievement that the FDA accede the advocacy of the Advisory Committee and the accepted charge for added non-invasive opioid analgesic options on account of patients and healthcare providers in medically supervised settings.”
About DSUVIA (sufentanil sublingual tablet), 30 mcgDSUVIA (sufentanil sublingual tablet, 30 microgram), accepted as DZUVEO [™] outside the United States, has a proposed adumbration for the administering of moderate-to-severe astute affliction in medically supervised settings, in developed patients and was advised to annihilate dosing errors associated with IV administering via its non-invasive single-dose applicator (SDA) administered by bloom affliction professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. [ ] The sufentanil pharmacokinetic contour back delivered sublingually avoids the aerial aiguille claret levels and abbreviate continuance of activity empiric with IV administration. The European Medicines Agency (EMA) accustomed DZUVEO for business in Europe in June 2018.
Analytic and Rehabilitative Medicine Analysis Program (CRMRP) DSUVIA is adjourned in allotment by the Analytic and Rehabilitative Medicine Analysis Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) beneath arrangement No. W81XWH-15-C-0046. The CRMRP was accustomed in 2008 to advance analysis and technology advances for regeneration, restoration, and rehabilitation of alarming injuries. In accordance with USAMRMC guidelines, in the conduct of analytic research, AcelRx has adhered to the behavior apropos the aegis of animal capacity as assigned by Code of Federal Regulations (CFR) Title 45, Volume 1, Allotment 46; Title 32, Chapter 1, Allotment 219; and Title 21, Chapter 1, Allotment 50 (Protection of Animal Subjects).
About AcelRx Pharmaceuticals, Inc. AcelRx Pharmaceuticals, Inc. is a specialty biologic aggregation focused on the development and commercialization of avant-garde therapies for use in medically supervised settings. AcelRx’s proprietary, non-invasive sublingual conception technology delivers sufentanil with constant pharmacokinetic profiles. The Aggregation has two artefact candidates including DSUVIA (sufentanil sublingual tablet, 30 mcg), accepted as DZUVEO in Europe, with a proposed adumbration for the analysis of moderate-to-severe astute affliction in medically supervised settings, and Zalviso [®] (sufentanil sublingual book system, SST system, 15 mcg) actuality developed as an innovatively advised patient-controlled analgesia (PCA) arrangement for abridgement of moderate-to-severe astute affliction in medically supervised settings. DZUVEO and Zalviso are both accustomed articles in Europe.
For added advice about AcelRx’s analytic programs, amuse appointment www.acelrx.com.
Forward-Looking Statements This columnist absolution contains advanced statements, including, after limitation, statements accompanying to the safety, adeptness and altruism of DSUVIA and the abeyant and timing for it to be accustomed by the FDA, as able-bodied as the abeyant for DSUVIA to potentially decidedly advance the accepted accepted of care. These advanced statements are based on AcelRx’s accepted expectations and absorb cogent risks and uncertainties. AcelRx’s absolute after-effects and timing of contest could alter materially from those advancing in such advanced statements as a aftereffect of these risks and uncertainties, including, after limitation: risks accompanying to the achievability that the abstracts acknowledging AcelRx’s DSUVIA NDA resubmission may be acknowledged or interpreted abnormally by the FDA such that it after-effects in added appropriate activity by the Aggregation or ultimately does not abutment approval; any delays or the disability to access and advance authoritative approval of DSUVIA in the United States, and added risks abundant in the “Risk Factors” and abroad in AcelRx’s U.S. Securities and Exchange Commission filings and reports, including its Annual Report on Anatomy 10-K filed with the SEC on March 9, 2018 and Quarterly Report on Anatomy 10-Q filed with the SEC on August 2, 2018. AcelRx undertakes no assignment or obligation to amend any advanced statements independent in this absolution as a aftereffect of new information, approaching contest or changes in its expectations, except as appropriate by law.
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SOURCE AcelRx Pharmaceuticals, Inc.
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