News Release

HAYWARD, Calif., Jan. 27, 2022 /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 of an article reviewing the use of sufentanil sublingual tablet (SST; DSUVIA^®) for pain medicine procedures by lead author Dr. Sarang Koushik in Current Pain and Headache Reports. Dr. Koushik is a board-certified anesthesiologist and Clinical Assistant Professor of Anesthesiology at the University of Southern California Keck School of Medicine.

Dr. Koushik's article entitled "A Review of Sublingual Sufentanil Tablet (SST) and its Utility as an Analgesic Agent for Pain Procedures" discusses the challenges presented by patients suffering from chronic pain who are undergoing pain medicine procedures. These patients often have difficult intravenous (IV) access due to repeated IV placements in the past. Furthermore, patients undergoing some of these procedures must provide real-time feedback to the physician performing the procedure which is difficult when the patient is over-sedated with IV sedative and analgesic drugs. The article highlights that the American Society of Interventional Pain Physicians recently opined that IV propofol should not be used as a sedative for pain procedures due to its risk of deep sedation and side effect profile, especially in the elderly.

In addition to SST having a non-invasive route of administration, the review article lists additional characteristics of SST, including "high bioavailability with avoidance of first-pass hepatic metabolism, rapid drug equilibration between central and peripheral compartments, the lack of active metabolites and a high therapeutic index." The article provides a detailed discussion of 23 published studies on SST assessing its safety and effectiveness in various medically supervised clinical settings. Lastly, the subject of SST as an option offering analgesia without the need for IV access or IV analgesics is discussed in the context of COVID-19-related social distancing requirements and drug shortages, as many IV sedatives and analgesics are on the FDA drug shortage list.

"In my experience, using SST as an analgesic for interventional procedures reduces the time and effort expended in obtaining IV access which can sometimes be challenging," states Dr. Koushik. "At the recent American Society of Regional Anesthesia and Pain Medicine Fall Meeting in November we reported on our success using SST during interventional procedures which previously had been quite painful for the patients. Notably the patients were comfortable, yet wide awake, which allowed for better patient-physician interaction during the procedure. We wrote this review article to bring attention to SST as an analgesic option for patients undergoing these pain procedures to improve procedural comfort while minimizing over-sedation."

"I know all too well the issues with IV analgesics and sedatives in this patient population as performing pain medicine procedures was my clinical area of expertise prior to starting AcelRx," said Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. "Dr. Koushik and his colleagues highlighted the issues with the current standard of care and the potential benefits of SST and conducted an extensive review of the SST literature."

Dr. Koushik and one of the co-authors of this article, Dr. Naum Shaparin, are paid consultants for AcelRx, but were not provided any funding related to this article.

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 it will be commercialized by AcelRx's European partner, Aguettant.

This release is intended for investors only.

LIMITATIONS OF USE
Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. Not for use for more than 72 hours.

The use of DSUVIA beyond 72 hours has not been studied. Only to be administered by a healthcare provider. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: have not been tolerated, or are not expected to be tolerated; have not provided adequate analgesia, or are not expected to provide adequate analgesia.

The Full Prescribing Information for DSUVIA contains the following Boxed Warning:

WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM; LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Accidental Exposure and DSUVIA Risk Evaluation and Mitigation Strategy (REMS) Program: Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, DSUVIA is only available through a restricted program called the DSUVIA REMS Program. DSUVIA must only be dispensed to patients in a certified medically supervised healthcare setting. Discontinue use of DSUVIA prior to discharge or transfer from the certified medically supervised healthcare setting.

Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of DSUVIA. Monitor for respiratory depression, especially during initiation of DSUVIA.

Addiction, Abuse, and Misuse: DSUVIA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing DSUVIA, and monitor all patients regularly for the development of these behaviors or conditions.

Cytochrome P450 3A4 Interaction: The concomitant use of DSUVIA with all cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration. Monitor patients receiving DSUVIA and any CYP3A4 inhibitor or inducer.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

IMPORTANT SAFETY INFORMATION
DSUVIA is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and known hypersensitivity to sufentanil or components of DSUVIA.

DSUVIA contains sufentanil, a Schedule II controlled substance. As an opioid, DSUVIA exposes users to the risks of addiction, abuse, and misuse. Potential serious adverse events caused by opioids include addiction, abuse, and misuse, life-threatening respiratory depression, neonatal withdrawal syndrome, risks of concomitant use or discontinuation of cytochrome P450 3A4 inhibitors and inducers, risks from concomitant use with benzodiazepines or other CNS depressants, risk of life threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients, adrenal insufficiency, severe hypotension, risks of use in patients with increased intracranial pressure or impaired consciousness, gastrointestinal disorders and seizure disorders. DSUVIA should be used with caution in patients with severe liver or kidney impairment.  

This is not a complete list of risks associated with DSUVIA. For additional Important Safety Information please see full Prescribing Information at www.DSUVIA.com.

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA^® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO^® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and several product candidates. The product candidates include Zalviso^® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S. being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings; two pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the U.S. from Aguettant; Niyad™, a regional anticoagulant for the extracorporeal circuit, and LTX-608, for the potential treatment of COVID-19, disseminated intravascular coagulation, acute respiratory distress syndrome and acute pancreatitis. DZUVEO and Zalviso are both approved products in Europe.

For additional information about AcelRx, please visit www.acelrx.com.

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SOURCE AcelRx Pharmaceuticals, Inc.

Investor, Raffi Asadorian, CFO, AcelRx, 650-216-3500, investors@acelrx.com