ACRX AcelRx Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
DSUVIA (Sufentanil)
Moderate-to-severe acute pain following a surgical procedure
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Approved
Approved
|
FDA Approval announced November 2, 2018.
|
|
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.
|
|
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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HAYWARD, Calif., June 17, 2021 /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 has reached agreement with the Food and Drug Administration (FDA) with regards to finalizing corrective actions AcelRx has taken or plans to take in response to the previously announced FDA warning letter, dated February 11, 2021, regarding certain DSUVIA promotional materials.
The FDA has agreed with AcelRx's proposed plan to update certain promotional materials, including providing a letter to healthcare professionals (DHCP letter) explaining the corrections to the discontinued promotional materials. AcelRx will also include this DHCP letter on the DSUVIA.com website for a period of eight months. All promotional materials currently in use by AcelRx's commercial team have been updated to address the FDA's concerns. AcelRx expects to receive a close-out letter from the FDA after the DHCP letters have been sent to the identified healthcare professionals and the letter has been posted on the website for eight months.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, 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 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 FDA warning letter, including the expected receipt of a close-out letter from the FDA. 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-agreement-with-fda-addressing-the-warning-letter-received-for-dsuvia-promotional-materials-301314559.htmlSOURCE AcelRx Pharmaceuticals, Inc.
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HAYWARD, Calif., June 1, 2021 /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 important findings from a podium presentation on DSUVIA (sufentanil sublingual tablet 30 mcg) during the Best Papers of the Regional Societies session at the California Society of Plastic Surgeons 71st Annual Meeting in Monterey CA.
The presentation entitled "The Use of Sublingual Sufentanil for Peri-operative Pain Management in an Outpatient and Clinic Setting" was presented on May 31, 2021 by Hisham Seify, MD, PhD, FACS and reported on data collected from a total of 76 patients during both short and long-duration general anesthesia plastic surgery cases as well as "awake" cosmetic procedures performed at the Newport Plastic and Reconstructive Surgery's center. Procedures were performed utilizing a single DSUVIA tablet in combination with general anesthesia. Patients undergoing short (< 1 hour) procedures required no opioids in the postanesthesia care unit (PACU) and had an average recovery time of 33 minutes with no adverse events reported. Following long-duration procedures, which often included multiple cosmetic procedures combined (averaging approximately 3 hours), 89% of the patients were opioid-free in the PACU, recovery time averaged 1 hour and the only adverse event was one patient that had nausea. Dr. Seify also presented his protocol for using DSUVIA during "awake" surgery cases and reported that to date they had seen no adverse events or vital sign instability in these patients. The data presented at the meeting are from an investigator-initiated trial supported by AcelRx. Dr. Seify is a paid consultant for AcelRx.
"The results from these 76 patients demonstrated that the use of DSUVIA allowed for enduring pain control into the postoperative period regardless of whether the surgical procedure was short or extensive, with little need for rescue opioids during recovery," states Dr. Seify. "The almost complete lack of adverse events experienced by these patients, including no sedating effects of DSUVIA, allowed us to discharge them in an hour or less, even when they underwent a 3-hour procedure," continues Dr. Seify.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, 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 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/rapid-discharge-with-minimal-pacu-opioids-was-key-message-during-presentation-of-dsuvia-for-analgesia-in-plastic-surgery-procedures-at-the-california-society-of-plastic-surgeons-annual-meeting-301302674.htmlSOURCE AcelRx Pharmaceuticals, Inc.
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HAYWARD, Calif., May 26, 2021 /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 an upcoming podium presentation on DSUVIA (sufentanil sublingual tablet 30 mcg) which was selected for the Best Papers of the Regional Societies session at the California Society of Plastic Surgeons 71st Annual Meeting in Monterey CA.
Hisham Seify, MD, PhD, FACS will present data on the efficacy and safety of DSUVIA for use in general anesthesia plastic surgery cases, and "awake" cosmetic procedures performed at the Newport Plastic and Reconstructive Surgery's center. The data is from an investigator-initiated trial supported by AcelRx. Dr. Seify is a board-certified plastic surgeon and the past-president of the Orange County Society of Plastic Surgeons.
Session Title: Best Papers of the Regional Societies
Presentation Title: The Use of Sublingual Sufentanil for Peri-operative Pain Management in an Outpatient and Clinic Setting
Session Date: Monday, May 31, 2021
Session Time: 8:30 am – 10:00 amAbout DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, 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 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/presentation-on-the-use-of-dsuvia-for-plastic-surgery-procedures-selected-for-best-papers-session-at-the-california-society-of-plastic-surgeons-annual-meeting-301299232.htmlSOURCE AcelRx Pharmaceuticals, Inc.
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HAYWARD, Calif., May 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 medically supervised settings, today announced an investigator-initiated study to be conducted at Tampa General Hospital to evaluate the use of DSUVIA for patients with sickle cell disease presenting to the emergency department (ED) with painful vaso-occlusive crisis (VOC).
The study will enroll 100 patients presenting to the emergency department with VOC who are administered DSUVIA to manage the patients' moderate-to-severe acute pain until an IV line can be accessed. The IV line is important for hydration, high-dose IV opioid administration as these patients are often opioid-tolerant, as well as administration of other parenteral medications. Endpoints will include the time from arrival in the ED to first analgesic medication, ED length of stay, hospital admission rates, patient and clinician satisfaction, and adverse events. Patients administered DSUVIA will be compared to a historical ED control group who received routine pain management for VOC, including waiting until IV access is established before opioids are administered.
The study's principal investigator is Jason Wilson, MD, MA, CPHQ, FACEP. Dr. Wilson is an attending emergency medicine physician serving as Director of the ED Clinical Decision Unit, Tampa General Hospital at TeamHealth. In this capacity, he is responsible for developing and implementing protocols and patient pathways that improve throughput metrics and quality of care for patients. Dr. Wilson also serves as an Associate Professor and core faculty for the University of South Florida College of Medicine, Division of Emergency Medicine, and as Research Director of the University of South Florida, Emergency Medicine Residency Program, Tampa General Hospital.
"I see patients with sickle cell disease presenting with VOC every day in the ED. I am working to establish trust with these patients who have often experienced a lifetime of under-controlled pain and frequent visits and readmissions to the hospital," states Dr. Wilson. "Often these patients have already tried oral medications at home and present to us with severe acute pain. Unfortunately, IV access can be difficult to obtain in these patients and often requires ultrasound-guided IV placement, which means it may take hours before patients receive strong opioid analgesics, which are the mainstay of treatment for their severe pain. Oral pain medication does not serve as a sufficient bridge and another option is needed. Our early experience with DSUVIA indicates that this rapid-onset sublingual option may be an effective analgesic bridge that manages pain while practitioners establish IV access in these opioid-tolerant patients, allowing early and proactive pain management in patients with VOC which could build trust in the patient encounter and avoid admissions," continued Dr. Wilson.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, 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 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, the scope of the study, expected analysis of clinical data, the potential for DSUVIA to be an effective analgesic bridge for patients with sickle cell disease presenting with VOC and the potential for proactive pain management in patients with VOC to build trust in the patient encounter and avoid admissions. 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-the-emergency-department-for-patients-with-sickle-cell-disease-301295941.htmlSOURCE AcelRx Pharmaceuticals, Inc.
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HAYWARD, Calif., May 17, 2021 /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 reported its first quarter 2021 financial results.
"We continue to make solid progress on the commercialization of DSUVIA despite the impact from the pandemic, which appears to be easing as the month of April was our highest commercial ordering month since the launch," said Vince Angotti, Chief Executive Officer of AcelRx. "We remain committed to building the body of evidence for DSUVIA and its unique benefit to healthcare providers and their patients by supporting real-world use studies in a number of different settings. We look forward to expected data read-outs from investigator-initiated studies with several prestigious institutions."
First Quarter and Recent Highlights
- In the first quarter of 2021, AcelRx issued approximately $36.4 million of stock through an underwritten public offering and under its At-the-Market sales agreement.
- In January 2021, AcelRx announced an investigator-initiated study with University Hospitals Cleveland Medical Center to evaluate the postoperative use of DSUVIA in a prospective cohort of patients undergoing cardiac surgery with cardiopulmonary bypass following a specialized enhanced recovery protocol.
- In February 2021, AcelRx announced an investigator-initiated study with Newport Plastic and Reconstructive Surgery Center analyzing data from the historical use of DSUVIA for various same-day plastic surgery procedures.
- In March 2021, AcelRx announced the publication of a pooled analysis of Phase 3 data on the use of DSUVIA for acute pain management in the postoperative and emergency department settings in the Journal of Pain Research, which reported high ratings for global assessment of the method of pain control and a well-tolerated safety profile for all demographic subgroups following the dosing of DSUVIA. See Cautionary Statements section below.
- In March 2021, AcelRx announced the appointment of Marina Bozilenko as an independent member of the company's Board of Directors. Ms. Bozilenko has over 30 years of investment banking and other healthcare industry experience, including raising more than $30 billion in capital and executing numerous M&A transactions.
- In April 2021, AcelRx announced an investigator-initiated study at Montefiore Medical Center evaluating the perioperative use of DSUVIA for same-day surgical procedures in patients on buprenorphine therapy for opioid-use disorder or for chronic pain management.
- In April 2021, the American Dental Association provided a CDT Code (Code on Dental Procedures and Nomenclature) establishing a pathway to reimbursement for DSUVIA for dental and oral surgeons.
- In May 2021, AcelRx announced an investigator-initiated study to be conducted at The CORE Institute Specialty Hospital in Phoenix, Arizona by the Musculoskeletal Orthopedic Research and Education (MORE) Foundation evaluating the perioperative use of DSUVIA for patients undergoing hip or knee replacement as a same-day surgical procedure.
- In May 2021, AcelRx announced a poster presentation at the 46th Annual American Society of Regional Anesthesia (ASRA) Meeting reviewing the results of a study on the intraoperative administration of DSUVIA (sufentanil sublingual tablet; SST) 30 mcg for the management of acute pain in an ambulatory surgery center.
- Through April 2021, AcelRx has achieved 432 formulary approvals.
- A response to the FDA Warning Letter has been provided and dialogue is ongoing to ensure a successful closeout. The Company believes it has successfully addressed the points raised. Once corrective actions are satisfactorily completed, AcelRx expects the FDA to issue a Close-Out Letter.
Financial Information
- Cash, cash equivalents and short-term investments balance of $67.3 million as of March 31, 2021;
- First quarter 2021 net revenues were $0.5 million;
- Combined R&D and SG&A expenses for the first quarter of 2021 totaled $8.6 million compared to $14.7 million for the first quarter of 2020. Excluding stock-based compensation expense, these amounts were $7.5 million for the first quarter of 2021 compared to $13.6 million for the first quarter of 2020. The decrease in combined R&D and SG&A expenses in the first quarter 2021 was primarily due to reductions in personnel-related costs, including travel expense, and DSUVIA-related commercialization expenses. For the first quarter of 2021, net loss was $9.0 million, or $0.08 per basic and diluted share, compared to $15.9 million, or $0.20 per basic and diluted share, for the first quarter of 2020.
Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast Monday, May 17, 2021 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx's website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx's website at www.acelrx.com.About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, 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 and AcelRx 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.
Non-GAAP Financial Measures
To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), AcelRx uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. AcelRx believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, AcelRx believes that these non-GAAP financial measures, when considered together with AcelRx's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare AcelRx's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track AcelRx's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate AcelRx's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.Cautionary Statements
Pooled Analysis. The global satisfaction analysis included a total of 283 patients who had completed the assessments as well as their healthcare professionals who had dosed DSUVIA in the clinical trials. Adverse events occurring in ≥ 2% of the patients were nausea (22.9%), headache (5.0%), dizziness (4.0%) and vomiting (3.1%). Importantly, the adverse events of decreased oxygen saturation and somnolence were low, occurring in 1.5% and 1.2% of the patients, respectively. Study limitations included a higher enrollment of younger compared to older patients, and opioid-tolerant patients were excluded. These Phase 3 studies were funded by AcelRx and the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the US Army Medical Research and Materiel Command (USAMRMC). The lead author, David Leiman, MD, University of Texas at Houston Department of Surgery and HD Research, Houston TX, is a paid consultant of AcelRx.Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the ongoing effects of the COVID-19 pandemic and its anticipated impacts on AcelRx's business, expectations for loosening of COVID-related restrictions, the expected continuation of investigator-initiated studies and the scope of the studies, the expected analysis and publication of clinical data, the belief that AcelRx has successfully addressed the points raised in the FDA Warning Letter, and the expectation that the FDA will issue a close-out letter once corrective actions are satisfactorily completed by AcelRx. 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 financial trends, 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, including the uncertainties inherent in the initiation, execution and completion of investigator-initiated studies. Although it is not possible to predict or identify all such risks and uncertainties, they 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. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. 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.Selected Financial Data
(in thousands, except per share data)
(unaudited)
Three Months Ended
March 31
2021
2020
Statement of Comprehensive Loss Data
Revenue:
Product sales
$ 451
$ 274
Contract and other collaboration
60
112
Total revenue
511
386
Operating costs and expenses:
Cost of goods sold (1)
1,040
1,511
Research and development (1)
969
1,412
Selling, general and administrative (1)
7,644
13,311
Total operating costs and expenses
9,653
16,234
Loss from operations
(9,142)
(15,848)
Other income (expense):
Interest expense
(672)
(855)
Interest income and other income (expense), net
76
(65)
Non-cash interest income on liability related to sale of future royalties
782
843
Total other income (expense)
186
(77)
Net loss
$ (8,956)
$ (15,925)
Basic and diluted net loss per common share
$ (0.08)
$ (0.20)
Shares used in computing basic and diluted net loss per common share
113,257
80,057
(1) Includes the following non-cash, stock-based compensation expense:
Cost of goods sold
$ 22
$ 46
Research and development
181
200
Selling, general and administrative
886
900
Total
$ 1,089
$ 1,146
March 31, 2021
December 31, 2020
Selected Balance Sheet Data
Cash, cash equivalents and investments
$ 67,345
$ 42,886
Total assets
87,347
66,295
Total liabilities
114,659
122,045
Total stockholders' deficit
(27,312)
(55,750)
Reconciliation of Non-GAAP Financial Measures
(Operating Expenses less associated stock-based compensation expense)
Three Months Ended
March 31
2021
2020
Operating expenses (GAAP):
Research and development
$ 969
$ 1,412
Selling, general and administrative
7,644
13,311
Total operating expenses
8,613
14,723
Less associated stock-based
compensation expense
1,067
1,100
Operating expenses (non-GAAP)
$ 7,546
$ 13,623
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-reports-first-quarter-2021-financial-results-301292151.htmlSOURCE AcelRx Pharmaceuticals, Inc.