ACRX AcelRx Pharmaceuticals Inc.

1.91
-0.04  -2%
Previous Close 1.95
Open 2
52 Week Low 0.7014
52 Week High 2.295
Market Cap $172,812,241
Shares 90,477,613
Float 89,327,144
Enterprise Value $161,058,345
Volume 8,608,098
Av. Daily Volume 2,868,639
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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

  1. REDWOOD CITY, Calif., Jan. 20, 2021 /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 the pricing of its underwritten public offering of 14.5 million shares of its common stock for gross proceeds of approximately $27.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by AcelRx. The offering is expected to close on or about January 22, 2021, subject to customary closing conditions. In addition, AcelRx has granted the underwriter a 30-day option to purchase up to approximately 2.2 million additional shares…

    REDWOOD CITY, Calif., Jan. 20, 2021 /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 the pricing of its underwritten public offering of 14.5 million shares of its common stock for gross proceeds of approximately $27.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by AcelRx. The offering is expected to close on or about January 22, 2021, subject to customary closing conditions. In addition, AcelRx has granted the underwriter a 30-day option to purchase up to approximately 2.2 million additional shares of common stock.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    The underwriter may offer the shares from time to time for sale in one or more transactions on the Nasdaq Global Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On January 19, 2021, the last sale price of the shares as reported on the Nasdaq Global Market was $2.35 per share.

    AcelRx intends to use the net proceeds from this offering for working capital and general corporate purposes, including commercialization activities, general and administrative expenses, research and development expenses, capital expenditures, and for making scheduled payments under its debt facility.

    The securities described above are being offered by AcelRx pursuant to a shelf registration statement previously filed with, and declared effective by, the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and the accompanying prospectus related to the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. Copies of the final prospectus and the accompanying prospectus relating to this offering may be obtained, when available, from Cantor Fitzgerald & Co., 499 Park Avenue, 6th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at ..

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

    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.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  2. REDWOOD CITY, Calif., Jan. 19, 2021 /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 underwritten public offering of its common stock. All shares to be sold in the offering will be sold by AcelRx, subject to customary closing conditions.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to an additional 15 percent of the number of shares offered in the public offering.

    AcelRx intends to use the net proceeds from this offering for working capital and…

    REDWOOD CITY, Calif., Jan. 19, 2021 /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 underwritten public offering of its common stock. All shares to be sold in the offering will be sold by AcelRx, subject to customary closing conditions.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to an additional 15 percent of the number of shares offered in the public offering.

    AcelRx intends to use the net proceeds from this offering for working capital and general corporate purposes, including commercialization activities, general and administrative expenses, research and development expenses, capital expenditures, and for making scheduled payments under its debt facility.

    The securities described above are being offered by AcelRx pursuant to a "shelf" registration statement on Form S-3 (File No. 333-239156) previously filed with the Securities and Exchange Commission (the "SEC") on June 12, 2020 and declared effective by the SEC on July 8, 2020. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, from Cantor Fitzgerald & Co., 499 Park Avenue, 6th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

    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.

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  3. REDWOOD CITY, Calif., Jan. 19, 2021 /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 University Hospitals (UH) Cleveland Medical Center that will evaluate the postoperative use of DSUVIA in a prospective cohort of patients undergoing cardiac surgery with cardiopulmonary bypass following a specialized enhanced recovery protocol. Dr. Daniel Asher, cardiac anesthesiologist and Medical Director of the Mather Postanesthesia Care Unit at UH Cleveland Medical Center, will serve as the principal investigator. Key outcomes to be measured…

    REDWOOD CITY, Calif., Jan. 19, 2021 /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 University Hospitals (UH) Cleveland Medical Center that will evaluate the postoperative use of DSUVIA in a prospective cohort of patients undergoing cardiac surgery with cardiopulmonary bypass following a specialized enhanced recovery protocol. Dr. Daniel Asher, cardiac anesthesiologist and Medical Director of the Mather Postanesthesia Care Unit at UH Cleveland Medical Center, will serve as the principal investigator. Key outcomes to be measured include time on mechanical ventilation following completion of the surgical procedure, both intensive care as well as hospital length of stay and total dose of opioids administered from surgery to discharge. These outcomes will be compared to historical controls utilizing current institutional standard of care techniques. 

    "We look forward to evaluating DSUVIA as part of our cardiac surgery enhanced recovery program which is aiming to better prepare our enrolled subjects for the stress of heart surgery by using contemporary preoperative adjuncts, educational tools, intraoperative monitoring techniques and, importantly, actively reducing the exposure of these patients to IV opioids and their side effects," states the study's co-investigator Dr. Edwin Avery, Vice Chair of Clinical Operations and Professor of Anesthesiology at UH Cleveland Medical Center, and Professor, Anesthesiology and Perioperative Medicine, Case Western Reserve University School of Medicine. "We believe the higher therapeutic index of sufentanil and the lower peak plasma concentrations delivered via the sublingual route compared to bolus IV administration will allow DSUVIA to help us achieve our goal," continues Dr. Avery.

    "This investigator-initiated study at UH Cleveland presents another opportunity to assess the benefits of DSUVIA compared to IV opioids," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. "The physicians at UH Cleveland Medical Center have chosen DSUVIA for evaluation in their enhanced recovery cardiac bypass program to determine if it provides effective pain relief while minimizing side effects during their postoperative recovery prior to discharge. This cardiac surgery study together with ongoing investigator-initiated trials of DSUVIA for orthopedic and spine surgeries at other top academic institutions allows DSUVIA to be assessed across a broad range of surgical subspecialties as an alternative to IV opioids."

    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.

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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  4. REDWOOD CITY, Calif., Jan. 14, 2021 /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 preliminary unaudited financial results and other information in connection with its participation in investor presentations, meetings and events during the week of the 39th Annual J.P. Morgan Healthcare Conference. The Company will post its revised corporate presentation in the investor section of its website.

    Key Highlights of 2020

    • DSUVIA® achieved Milestone C approval from the Department of Defense (DoD), a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits…

    REDWOOD CITY, Calif., Jan. 14, 2021 /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 preliminary unaudited financial results and other information in connection with its participation in investor presentations, meetings and events during the week of the 39th Annual J.P. Morgan Healthcare Conference. The Company will post its revised corporate presentation in the investor section of its website.

    Key Highlights of 2020

    • DSUVIA® achieved Milestone C approval from the Department of Defense (DoD), a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits (SKOs). Initial stocking orders have begun for U.S. Army SKOs and are expected to approximate $30 million over the next three years, dependent on troop deployment schedules.



    • In March, AcelRx announced an agreement with Brigham and Women's Hospital for an investigator-initiated study of DSUVIA led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School. This study is ongoing and is evaluating the perioperative use of DSUVIA in patients undergoing spine surgery compared to their standard intravenous (IV) opioid regimen.



    • In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA within the dental and oral surgery markets in the United States exclusively through Zimmer Biomet's Dental division. The formal launch is planned in 2021, once Zimmer Biomet receives necessary licenses. The estimated applicable market in dental surgeries is over 7 million annual procedures.



    • In August, AcelRx announced the publication of a study entitled, "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 (Tvetenstrand and Wolff Study). Highlights of the publication included a greater than 50% overall reduction in opioids administered perioperatively and a 34% reduction in postanesthesia care unit (PACU) time in the DSUVIA-treated patients compared to historical controls. See Cautionary Statements section below.



    • In August, AcelRx announced an investigator-initiated study with Cleveland Clinic evaluating the effects of DSUVIA on post-operative recovery from orthopedic surgery. This double-blind study is ongoing and compares DSUVIA to IV fentanyl for patients undergoing knee arthroscopy.



    • In September, AcelRx announced that the U.S. military's access to DSUVIA was expanded with the addition of DSUVIA to the DoD Joint Deployment Formulary.



    • In September, the U.S. Army awarded AcelRx a contract of up to $3.6 million over four years for the purchase of DSUVIA to support a DoD study to aid the development of clinical practice guidelines.



    • In December, AcelRx announced the publication of clinical data in an article in the Journal of Universal Surgery entitled, "A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain," by lead author Koth Cassavaugh, PharmD, Director of Pharmacy (the Cassavaugh Evaluation), which reported that perioperative dosing of DSUVIA can provide more rapid PACU recovery times compared to standard IV opioid administration. In addition, patients in the control group received 66% higher mean dosing of intraoperative IV opioids compared to patients receiving DSUVIA and postoperative opioid use for the DSUVIA group was less than half of the control IV opioid group, with orthopedic surgery patients having the largest decrease (69%). See Cautionary Statements section below.



    • Achieved 348 formulary approvals through the close of 2020, a significant achievement in a year with COVID-related restrictions and delays.



    • Preliminary unaudited FY 2020 revenues approximated $5.4 million.



    • Preliminary December 31, 2020 cash, cash equivalents and short-term investments balance was $42.9 million.

    "I'm pleased with our team's commercial execution during these challenging times," said Vince Angotti, AcelRx Chief Executive Officer.  "We expect further real-world data to support the value proposition of DSUVIA as an alternative to IV opioids, and we continue to make solid progress on the four pillars of our revenue plan.  I look forward to providing further updates during our year-end earnings call."

    The information above related to the Company's expected operating results for the year ended and as of December 31, 2020, including revenue and cash, cash equivalents and short-term investments, is preliminary, has not been audited and is subject to change upon completion of the audit of the Company's financial statements as of and for the year ended December 31, 2020.

    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. AcelRx 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.

    Cautionary Statements

    Tvetenstrand and Wolff Study

    The study compared a prospective group of patients with preoperative dosing of a single sublingual DSUVIA tablet to a historical control group receiving standard intravenous (IV) opioid administration for same-day general surgery procedures. A total of 127 patients were evaluated in the study. Study limitations include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients. AcelRx did not provide funding for the conduct of the Tvetenstrand and Wolff Study but did fund medical writing support. Dr. Tvetenstrand is a paid consultant of AcelRx.

    Cassavaugh Evaluation

    The evaluation focused on 140 patients who were dosed with DSUVIA compared to 158 patients who had been dosed with traditional IV opioids during the same time period undergoing the same surgical procedures. Study limitations included that it was a single-center, retrospective study of DSUVIA dosing in a surgical patient population and both inpatient and outpatient surgery data was combined. The study did not control for whether patients were opiate naïve or opiate tolerant in the treatment groups, however, there is no reason for these patients to be present at a substantially higher frequency in either group. AcelRx did not provide funding for the conduct of the evaluation but did fund medical writing support. Dr. Cassavaugh is a paid consultant of AcelRx.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to revenues and cash, cash equivalents and short-term investments AcelRx expects to report for fiscal year 2020, the timing of the procurement of DSUVIA by the military, the timing of the formal launch by Zimmer Biomet, and expectations for further real-world data to support the value proposition of DSUVIA as an alternative to IV opioids. 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. 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 AcelRx'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. Except to the extent required by law, AcelRx 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.

     

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  5. REDWOOD CITY, Calif., Dec. 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 the publication by the Journal of Universal Surgery of clinical data on the use of DSUVIA for acute perioperative pain management.

    The article entitled "A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain" by lead author Koth Cassavaugh, PharmD, Director of Pharmacy, reports that perioperative dosing of the sublingual sufentanil tablet 30 mcg (SST; DSUVIA) can provide enhanced postanesthesia care unit (PACU) recovery compared…

    REDWOOD CITY, Calif., Dec. 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 the publication by the Journal of Universal Surgery of clinical data on the use of DSUVIA for acute perioperative pain management.

    The article entitled "A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain" by lead author Koth Cassavaugh, PharmD, Director of Pharmacy, reports that perioperative dosing of the sublingual sufentanil tablet 30 mcg (SST; DSUVIA) can provide enhanced postanesthesia care unit (PACU) recovery compared to standard intravenous (IV) opioid administration. The evaluation was conducted at Auburn Community Hospital, Auburn, NY, and included 298 patients in a perioperative setting undergoing a wide variety of inpatient and outpatient procedures including abdominal, orthopedic, gynecologic, genitourinary, otolaryngologic and spinal surgeries.

    The evaluation focused on 140 patients who were dosed with SST 30 mcg compared to 158 patients who had been dosed with traditional IV opioids during the same time period undergoing the same surgical procedures. Key findings included the following:

    • Intraoperative IV opioid use – patients in the control group overall received 66% higher mean dosing of intraoperative IV opioids compared to patients receiving SST (p<0.001).

       
    • Postoperative opioid use – the mean opioid requirement of the SST group was less than half of the control group (p<0.001), with orthopedic surgery patients having the largest decrease (69%).

       
    • PACU time to discharge – Phase 1 recovery time in the PACU was reduced by an average of 14 minutes across patients in the SST group compared with the control group (p<0.001), with the largest decrease in recovery time observed among abdominal surgery patients (23 minutes; 25% reduction).

       
    • Respiratory depression – 3 patients in the control group required naloxone use for respiratory depression whereas no patients in the SST group required naloxone use.

    The authors concluded that overall, SST dosed preoperatively or intraoperatively, significantly reduced both PACU opioid dosing requirements and Phase 1 unit discharge time compared to control patients receiving standard IV opioids intraoperatively. SST was well tolerated with no significant adverse events. In addition, the authors noted that decreasing discharge time per patient can have a substantial financial impact when multiplied over thousands of patients each year taking into account surgical throughput inefficiency that congestion in the PACU creates. Study limitations include that it was a single-center, retrospective study of SST dosing in a surgical patient population and both inpatient and outpatient surgery data was combined. The study did not control for whether patients were opiate naïve or opiate tolerant in the treatment groups, however, there is no reason for these patients to be present at a substantially higher frequency in either group. AcelRx did not provide funding for the conduct of the evaluation but did fund medical writing support. AcelRx did not provide any compensation to the authors for the evaluation.  Dr. Cassavaugh is a paid consultant of AcelRx.

    "We are thrilled this clinical data supports DSUVIA as a well-tolerated and effective pain management solution across a wide variety of both inpatient and outpatient surgical procedures, and also indicates shorter patient recovery time and economic benefits for hospitals," said Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. "Importantly, the findings of reduced overall IV opioid use and PACU discharge time are consistent with other recently published clinical data on the use of DSUVIA in the perioperative environment."

    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. AcelRx 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.

     

    AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

     

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    SOURCE AcelRx Pharmaceuticals, Inc.

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