ACRX AcelRx Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
|
Phase 3
Phase 3
|
CRL Jul 26 2014. NDA resubmission planned.
|
|
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure
|
Approved
Approved
|
FDA Approval announced November 2, 2018.
|
|
ARX-04 (SAP302)
Patients who presented to emergency departments with moderate-to-severe acute pain associated with trauma or injury
|
Phase 3
Phase 3
|
Phase 3 data released August 15 2016
|
Latest News
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REDWOOD CITY, Calif., Sept. 29, 2020 /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 it will host a virtual Key Opinion Leader (KOL) event on the perioperative use of DSUVIA, on Wednesday, October 7, 2020 at 12 pm ET (9 am PT).
The event will feature discussions and data presentations from two separate studies on the perioperative administration of DSUVIA with Dr. Christian Tvetenstrand, Chairman of Surgery and Director of Trauma, United Health Services Wilson Medical Center, New York, and Dr. Koth Cassavaugh, Director of Pharmacy, Auburn Community Hospital.
Dr. Tvetenstrand will present data from a recent publication, "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting" by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management. Dr. Cassavaugh will present data from a recently completed perioperative study of DSUVIA across multiple types of surgical specialties at Auburn Community Hospital that has been submitted for publication.
The live webcast of the event can be accessed by using the following link: https://event.webcasts.com/starthere.jsp?ei=1379798&tp_key=a00647f588 or by clicking on the webcast link on the Investors home page of the company's website at www.acelrx.com.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, 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. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit 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), an investigational product in the U.S., is 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.For additional information about AcelRx, please visit www.acelrx.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-to-host-virtual-kol-event-on-perioperative-use-of-dsuvia-301139817.htmlSOURCE AcelRx Pharmaceuticals, Inc.
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REDWOOD CITY, Calif., Sept. 22, 2020 /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 that the U.S. Army has awarded AcelRx with an initial contract of up to approximately $3.6 million for the purchase of DSUVIA to support a study to aid the development of clinical practice guidelines. Orders under the contract may be fulfilled over the next four years as specified in the agreement, with an initial purchase expected this year.
"We are excited to receive this initial contract award for DSUVIA, which exemplifies the continued momentum with the Department of Defense," said Vince Angotti, Chief Executive Officer at AcelRx Pharmaceuticals. "This award is in addition to expected purchases from the U.S. Army for the initial stocking of their medical assemblages, sets, kits and outfits for troop deployment, as well as potential orders from other branches of the military following the recent approval of DSUVIA onto the Joint Deployment Formulary. We believe that DSUVIA's unique pharmacokinetic profile, high therapeutic index, and efficient sublingual delivery will position it as a key option for acute pain management across all branches of the military," continued Mr. Angotti.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, 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. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.
This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit 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), an investigational product in the U.S., is 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.
For additional information about AcelRx, please visit www.acelrx.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the expected purchasing of DSUVIA by the military and DSUVIA being positioned as a key option for acute pain management across all branches of the military. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition, such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-awarded-us-army-contract-for-dsuvia-301135341.htmlSOURCE AcelRx Pharmaceuticals, Inc.
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REDWOOD CITY, Calif., Sept. 14, 2020 /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 that the U.S. military's access to DSUVIA has been expanded with the addition of DSUVIA to the Department of Defense's Joint Deployment Formulary (JDF). The JDF is a core list of pharmaceutical products that are designated for deploying military units across all service branches.
"DSUVIA's addition to the Joint Deployment Formulary continues to validate its importance as a key option in the treatment of acute pain and represents yet another significant milestone for AcelRx," said Vince Angotti, Chief Executive Officer at AcelRx Pharmaceuticals. "DSUVIA's advancement within the military coupled with recently published data showing how DSUVIA enhances recovery times in the post-operative setting supports the increasing momentum for DSUVIA use and allows more healthcare practitioners to experience DSUVIA's unique pharmacokinetic characteristics," stated Mr. Angotti.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, 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. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit 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), an investigational product in the U.S., is 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.For additional information about AcelRx, please visit www.acelrx.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the expected use of DSUVIA by more healthcare practitioners. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition, such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-announces-dsuvia-added-to-the-us-department-of-defenses-joint-deployment-formulary-301129926.htmlSOURCE AcelRx Pharmaceuticals, Inc.
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REDWOOD CITY, Calif., Sept. 10, 2020 /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 that management will be providing an overview of the business and company updates at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference taking place September 14-16, 2020, and at the Cantor Fitzgerald Virtual Global Healthcare Conference taking place September 15-17, 2020.
Details of the events are as follows:
H.C. Wainwright & Co. 22nd Annual Global Investment Conference
Date: Monday, September 14, 2020
Presentation Time: 4:30 PM Eastern Time / 1:30 PM Pacific TimeCantor Fitzgerald Virtual Global Healthcare Conference
Date: Wednesday, September 16, 2020
Presentation Time (Fireside Chat): 4:00 PM Eastern Time / 1:00 PM Pacific TimeA live webcast link of both of the events can be found on the Company's website at http://ir.acelrx.com/upcoming-events. Management will also be hosting one-on-one investor meetings throughout the day.
For those not available to listen to the live webcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.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. Zalviso is not approved in the U.S. For additional information about AcelRx, please visit www.acelrx.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-to-present-at-two-upcoming-conferences-301127962.htmlSOURCE AcelRx Pharmaceuticals, Inc.
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REDWOOD CITY, Calif., Aug. 24, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an investigator-initiated study with Cleveland Clinic. The study will assess the effects of DSUVIA on post-operative recovery from orthopedic surgery.
"A recently published study and preliminary data from other open-label studies using DSUVIA in the perioperative environment suggest a substantial decline in the amount of opioids used in the PACU, and a dramatic decrease in time to discharge from the PACU with DSUVIA-treated patients compared to historical controls," states Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. "By supporting investigator-initiated, double-blind studies conducted at highly respected institutions, we look to further demonstrate the benefits of DSUVIA in the intra- and post-operative environment. We also look forward to additional studies of the effectiveness, efficiency and safety of DSUVIA in settings outside the post-surgical arena. We strongly believe the findings from all of these trials will further support DSUVIA becoming a key analgesic medication for the management of acute pain in medically supervised settings," continued Dr. Palmer.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, 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. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit 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), an investigational product in the U.S., is 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.For additional information about AcelRx, please visit www.acelrx.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to expected commencement of an investigator-initiated study and the scope of the study, expected findings from the investigator-initiated study and other studies, and the expected commencement of additional studies. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition, such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-announces-an-investigator-initiated-study-of-dsuvia-in-orthopedic-patients-in-the-perioperative-setting-301116751.htmlSOURCE AcelRx Pharmaceuticals, Inc.