We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
AcelRX Pharmaceuticals Inc | NASDAQ:ACRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.86 | 0.861 | 0.89 | 0 | 01:00:00 |
REDWOOD CITY, Calif., April 11, 2019 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced an abstract about the safety of DSUVIA™ has been selected, as one of the highest scoring abstracts, for a moderated presentation at the 44th Annual Regional Anesthesiology & Acute Pain Medicine Meeting taking place from April 11-13 in Las Vegas, Nevada. The e-poster is available online at http://epostersonline.s3.amazonaws.com/asraspring2019/asraspring2019.1bd06f2.NORMAL.pdf
This oral presentation covers the pooled safety results from over 800 clinical study patients ranging in age from 18 to 86. The objective of the analysis performed was to evaluate the pooled safety data by age group from the clinical studies of sufentanil sublingual tablets in both postoperative and emergency department patients.
"We are pleased to have one of the highest scoring abstracts and be selected to present at ASRA's 2019 Spring meeting," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. "These pooled results from our numerous clinical trials support the safe use of sufentanil sublingual tablets across a broad age range of patients in the emergency department and following a wide variety of surgeries."
DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death. Please see the full Indication, Limitations of use and Important Safety Information, including the Boxed Warning below.
Details on the presentation are as follows: | |
Title: | Pooled Safety Results by Age Cohort for the Overall Sufentanil Sublingual Tablet 30 mcg Safety Population |
Presenter: | Dr. David Leiman - Clinical Assistant Professor of Surgery & Director of HD Research Corp, University of Texas at Houston |
Date/Time: | Friday, April 12, 2019 at 4:00-5:30PM. |
Location: | Caesars Palace, Las Vegas, Nevada |
About DSUVIA (sufentanil) sublingual tablet
Indications and Usage
DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
PLEASE SEE BELOW FOR THE IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
IMPORTANT SAFETY INFORMATION
WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM; LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Accidental Exposure and DSUVIA Risk Evaluation and Mitigation Strategy (REMS) Program
Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, DSUVIA is only available through a restricted program called the DSUVIA REMS Program.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of DSUVIA. Monitor for respiratory depression, especially during initiation of DSUVIA.
Addiction, Abuse, and Misuse
DSUVIA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing DSUVIA, and monitor all patients regularly for the development of these behaviors or conditions.
Cytochrome P450 3A4 Interaction
The concomitant use of DSUVIA with all cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration. Monitor patients receiving DSUVIA and any CYP3A4 inhibitor or inducer.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Contraindications
Use of DSUVIA is contraindicated in patients with:
Warnings and Precautions
Adverse Reactions
Adverse reactions are described, or described in greater detail, in other sections of the Prescribing Information:
The most commonly reported adverse reactions (≥ 2% and higher than placebo) were nausea, headache, vomiting, dizziness, and hypotension.
Medical Information
For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact the AcelRx Medical Information Contact Center at 1-855-925-8476 or AcelRxMedInfo@rmpdc.org.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information and Directions For Use at www.dsuvia.com.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso®(sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe. In the U.S., Zalviso is an investigational drug and not approved. For additional information about AcelRx, please visit www.acelrx.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-pooled-safety-results-for-sufentanil-sublingual-tablets-dsuvia-selected-for-presentation-at-44th-annual-regional-anesthesiology--acute-pain-medicine-meeting-300831047.html
SOURCE AcelRx Pharmaceuticals, Inc.
Copyright 2019 PR Newswire
1 Year AcelRX Pharmaceuticals Chart |
1 Month AcelRX Pharmaceuticals Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions