REDWOOD CITY, Calif., Oct. 31, 2016/PRNewswire/ - AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a claim to fame pharmaceutical organization concentrated on the improvement and commercialization of creative treatments for the treatment of direct to-extreme intense torment, reported an up and coming publication presentation at The Obesity Society Annual Meeting, which is occurring October 31 - November 4, 2016 in New Orleans, LA.
This publication presents information that demonstrates that large patients treated with ARX-04 (sufentanil sublingual tablet, 30 mcg) in the Phase 3 SAP301 concentrate on taking after walking stomach surgery experienced more noteworthy torment alleviation over the 12-hour consider period (SPID-12) contrasted with those treated with a fake treatment. The experience of hefty patients in the study was like that of patients with lower BMIs. Sickness (23%) and cerebral pain (10%) were the main unfriendly occasions reported by more than one patient in the large partner treated with ARX-04. Generally speaking, while test sizes were restricted, the finish of this investigation was that wellbeing and adequacy results were predictable over the whole study populace, paying little heed to BMI.
Subtle elements on the presentations are as per the following:
Date:
Friday, November fourth, 12:00 – 1:30 p.m. (neighborhood time)
Title:
The Sufentanil Sublingual 30mcg Tablet and Effect of BMI on Post-Operative Pain Management Following Outpatient Abdominal Surgery
Creators:
Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Shankar Lakshman, MD of Lotus Clinical Research in Pasadena, CA; Timothy Melson, MD of the Helen Keller Hospital in Sheffield, AL; David Leiman, MD of the Victory Medical Center in Houston, TX; and Karen DiDonato, MSN, RN and Pamela Palmer, MD, PhD of AcelRx Pharmaceuticals
Dr. Pamela Palmer, boss therapeutic officer and fellow benefactor of AcelRx included, "Corpulent patients require cautious weight-based dosing regimens when utilizing numerous opioid torment solutions, for example, morphine. The proof from this study recommends that ARX-04 has the potential for altered measurement torment administration for these patients."
ObesityWeek is a remarkable, global occasion concentrated on the essential science, clinical application, surgical mediation and counteractive action of heftiness. By consolidating both American Society for Metabolic and Bariatric Surgery (ASMBS) and The Obesity Society (TOS) yearly gatherings, ObesityWeek unites widely acclaimed specialists in stoutness to share advancement and leaps forward in science unmatched around the world. Participants will appreciate the differing instructive open doors, organizing occasions, and logical cooperative energies made through the joint effort of these driving heftiness associations. More data might be found at http://obesityweek.com.
Clinical and Rehabilitative Medicine Research Program (CRMRP)
ARX-04 is supported to some extent by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Armed force Medical Research and Materiel Command (USAMRMC) under get No. W81XWH-15-C-0046. The CRMRP was set up in 2008 to encourage research and innovation progresses for recovery, rebuilding, and restoration of traumatic wounds.
As per USAMRMC rules, in the lead of clinical research, AcelRx has clung to the arrangements with respect to the insurance of human subjects as recommended by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).
About ARX-04
ARX-04 is a non-intrusive investigational item hopeful comprising of 30 mcg sufentanil tablets conveyed sublingually by a social insurance proficient utilizing a dispensable, pre-filled, single-dosage utensil (SDA). Sufentanil is an engineered opioid pain relieving with a high restorative file and no known dynamic metabolites.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a claim to fame pharmaceutical organization concentrated on the improvement and commercialization of imaginative treatments for the treatment of direct to-extreme intense agony. The Company's late-organize pipeline incorporates ARX-04 (sufentanil sublingual tablet, 30 mcg), intended for the treatment of direct to-serious intense torment in restoratively regulated settings; and Zalviso® (sufentanil sublingual tablet framework), intended for the administration of direct to-extreme intense agony in grown-up patients in the healing facility setting. Zalviso conveys 15 mcg sufentanil sublingually through a non-intrusive conveyance course by means of a pre-customized, quiet controlled absense of pain gadget. Zalviso is endorsed in the EU and additionally Norway, Iceland, and Liechtenstein and is investigational and in late-arrange improvement in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx holds all other overall rights.
For extra data about AcelRx's clinical projects, please visit www.acelrx.com.
Forward-Looking Statements
This official statement contains forward-looking articulations, including, yet not constrained to, explanations identified with the procedure and timing of foreseen future improvement of AcelRx's item competitors, ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso® (sufentanil sublingual tablet framework), including the ARX-04 clinical trial comes about; expected accommodation of the New Drug Application, or NDA, for ARX-04 to the U.S. Nourishment and Drug Administration, or FDA; AcelRx's pathway forward towards picking up endorsement of Zalviso in the U.S.; expected resubmission of the Zalviso NDA to the FDA; and the helpful and business capability of AcelRx's item competitors, including potential market open doors for ARX-04 and Zalviso. These forward-looking proclamations depend on AcelRx Pharmaceuticals' present desires and characteristically include huge dangers and vulnerabilities. AcelRx Pharmaceuticals' genuine results and timing of occasions could vary substantially from those foreseen in such forward-looking explanations, and as an aftereffect of these dangers and instabilities, which incorporate, without confinement, dangers identified with AcelRx Pharmaceuticals' ARX-04 advancement program, including expected accommodation of the ARX-04 NDA and resubmission of the Zalviso NDA; the indeterminate clinical improvement handle; the achievement, cost and timing of all advancement exercises and clinical trials; and different dangers definite in the "Hazard Factors" and somewhere else in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q documented with the SEC on July 29, 2016. AcelRx attempts no obligation or commitment to overhaul any forward-looking explanations contained in this discharge as a consequence of new data, future occasions or changes in its desires.
This publication presents information that demonstrates that large patients treated with ARX-04 (sufentanil sublingual tablet, 30 mcg) in the Phase 3 SAP301 concentrate on taking after walking stomach surgery experienced more noteworthy torment alleviation over the 12-hour consider period (SPID-12) contrasted with those treated with a fake treatment. The experience of hefty patients in the study was like that of patients with lower BMIs. Sickness (23%) and cerebral pain (10%) were the main unfriendly occasions reported by more than one patient in the large partner treated with ARX-04. Generally speaking, while test sizes were restricted, the finish of this investigation was that wellbeing and adequacy results were predictable over the whole study populace, paying little heed to BMI.
Subtle elements on the presentations are as per the following:
Date:
Friday, November fourth, 12:00 – 1:30 p.m. (neighborhood time)
Title:
The Sufentanil Sublingual 30mcg Tablet and Effect of BMI on Post-Operative Pain Management Following Outpatient Abdominal Surgery
Creators:
Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Shankar Lakshman, MD of Lotus Clinical Research in Pasadena, CA; Timothy Melson, MD of the Helen Keller Hospital in Sheffield, AL; David Leiman, MD of the Victory Medical Center in Houston, TX; and Karen DiDonato, MSN, RN and Pamela Palmer, MD, PhD of AcelRx Pharmaceuticals
Dr. Pamela Palmer, boss therapeutic officer and fellow benefactor of AcelRx included, "Corpulent patients require cautious weight-based dosing regimens when utilizing numerous opioid torment solutions, for example, morphine. The proof from this study recommends that ARX-04 has the potential for altered measurement torment administration for these patients."
ObesityWeek is a remarkable, global occasion concentrated on the essential science, clinical application, surgical mediation and counteractive action of heftiness. By consolidating both American Society for Metabolic and Bariatric Surgery (ASMBS) and The Obesity Society (TOS) yearly gatherings, ObesityWeek unites widely acclaimed specialists in stoutness to share advancement and leaps forward in science unmatched around the world. Participants will appreciate the differing instructive open doors, organizing occasions, and logical cooperative energies made through the joint effort of these driving heftiness associations. More data might be found at http://obesityweek.com.
Clinical and Rehabilitative Medicine Research Program (CRMRP)
ARX-04 is supported to some extent by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Armed force Medical Research and Materiel Command (USAMRMC) under get No. W81XWH-15-C-0046. The CRMRP was set up in 2008 to encourage research and innovation progresses for recovery, rebuilding, and restoration of traumatic wounds.
As per USAMRMC rules, in the lead of clinical research, AcelRx has clung to the arrangements with respect to the insurance of human subjects as recommended by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).
About ARX-04
ARX-04 is a non-intrusive investigational item hopeful comprising of 30 mcg sufentanil tablets conveyed sublingually by a social insurance proficient utilizing a dispensable, pre-filled, single-dosage utensil (SDA). Sufentanil is an engineered opioid pain relieving with a high restorative file and no known dynamic metabolites.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a claim to fame pharmaceutical organization concentrated on the improvement and commercialization of imaginative treatments for the treatment of direct to-extreme intense agony. The Company's late-organize pipeline incorporates ARX-04 (sufentanil sublingual tablet, 30 mcg), intended for the treatment of direct to-serious intense torment in restoratively regulated settings; and Zalviso® (sufentanil sublingual tablet framework), intended for the administration of direct to-extreme intense agony in grown-up patients in the healing facility setting. Zalviso conveys 15 mcg sufentanil sublingually through a non-intrusive conveyance course by means of a pre-customized, quiet controlled absense of pain gadget. Zalviso is endorsed in the EU and additionally Norway, Iceland, and Liechtenstein and is investigational and in late-arrange improvement in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx holds all other overall rights.
For extra data about AcelRx's clinical projects, please visit www.acelrx.com.
Forward-Looking Statements
This official statement contains forward-looking articulations, including, yet not constrained to, explanations identified with the procedure and timing of foreseen future improvement of AcelRx's item competitors, ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso® (sufentanil sublingual tablet framework), including the ARX-04 clinical trial comes about; expected accommodation of the New Drug Application, or NDA, for ARX-04 to the U.S. Nourishment and Drug Administration, or FDA; AcelRx's pathway forward towards picking up endorsement of Zalviso in the U.S.; expected resubmission of the Zalviso NDA to the FDA; and the helpful and business capability of AcelRx's item competitors, including potential market open doors for ARX-04 and Zalviso. These forward-looking proclamations depend on AcelRx Pharmaceuticals' present desires and characteristically include huge dangers and vulnerabilities. AcelRx Pharmaceuticals' genuine results and timing of occasions could vary substantially from those foreseen in such forward-looking explanations, and as an aftereffect of these dangers and instabilities, which incorporate, without confinement, dangers identified with AcelRx Pharmaceuticals' ARX-04 advancement program, including expected accommodation of the ARX-04 NDA and resubmission of the Zalviso NDA; the indeterminate clinical improvement handle; the achievement, cost and timing of all advancement exercises and clinical trials; and different dangers definite in the "Hazard Factors" and somewhere else in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q documented with the SEC on July 29, 2016. AcelRx attempts no obligation or commitment to overhaul any forward-looking explanations contained in this discharge as a consequence of new data, future occasions or changes in its desires.
No comments:
Post a Comment
Note: only a member of this blog may post a comment.