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Share Name | Share Symbol | Market | Type |
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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 | |
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0.00 | 0.00% | 0.86 | 0.861 | 0.89 | 0 | 01:00:00 |
REDWOOD CITY, Calif., Jan. 7, 2019 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication of a pooled analysis in the peer reviewed journal, Pain Management, analyzing the results of AcelRx's clinical studies to assess safety of sufentanil sublingual tablets for the short-term treatment of moderate-to-severe acute pain in medically supervised settings.
The objective of the safety analysis was to evaluate the pooled data from AcelRx's clinical studies of sufentanil sublingual tablets (SSTs) administered at 30 mcg dose equivalents over ≤ 72 hours for moderate-to-severe acute pain management in both postoperative and emergency room patients. Analysis included a subset of patients from SST 15 mcg studies where patients received the first two doses of SST 15 mcg within the first 20–25 min (representing a 30-mcg dose-equivalent). Overall, 804 patients were evaluated in the pooled safety analysis, including 646 that had received the active drug. Across all of the AcelRx studies, adverse events (AEs) were experienced by 60.5% of patients in the SST group, and 61.4% in the placebo group. The most common treatment-related AEs experienced by patients treated with SST were nausea (28.5%), vomiting (6.5%) and headache (5.0%). Findings from the pooled analysis support that short-term (≤72 hours) administration of SST is well tolerated, with most adverse events considered mild or moderate in severity.
The publication also noted the additional safety assessment measuring cognitive impairment, which AcelRx had performed in one open-label SST 30 mcg study in emergency room patients (Study SAP302). A total of 75 patients were dosed with SST 30 mcg and evaluated predose and 1 hour postdose for cognitive impairment using the validated Six-item Screener tool. In 97.3% of the patients, the score stayed the same or improved following a dose of SST 30 mcg.
"In my experience treating emergency trauma and injury patients with DSUVIA, the overall adverse event profile, and lack of cognitive impairment following treatment with DSUVIA, supports the importance of this non-invasive opioid as a well-tolerated treatment option for moderate-to-severe acute pain management in hospitals," said Dr. James Miner, Chief of Emergency Medicine at Hennepin Healthcare and lead investigator in the DSUVIA Emergency Department Study SAP302.
Active-Comparator Study Design and Dosing Equivalence
This safety analysis also evaluated the morphine equivalence of SSTs from 357 patients in AcelRx's active-comparator study evaluating two patient-controlled analgesia (PCA) systems. Within the first 5 hours after initiation of treatment with either SST 15 mcg PCA (20-minute lockout) or IV morphine 1 mg PCA (6-minute lockout), SST 15 mcg was calculated to be dose-equivalent to approximately 2.5 mg IV morphine based on drug utilization in each treatment group over this 5 hour period (or 5 mg IV morphine for 30 mcg SST). Zalviso is not approved in the U.S.
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. Zalviso is not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.
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.
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SOURCE AcelRx Pharmaceuticals, Inc.
Copyright 2019 PR Newswire
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