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Pharmacology

DSUVIA is the first sublingual formulation
of sufentanil, an opioid analgesic

DSUVIA is indicated for the management of acute pain,
severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adults. DSUVIA is for use in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments.

Please see Limitations of Use and BOXED WARNING under Important Safety Information below.

Why sublingual sufentanil?

Absorption

Lipid-soluble sufentanil is readily absorbed through sublingual tissues and crosses the blood-brain barrier in minutes.1

sufentanil

Plasma:CNS
equilibration half-life
˜6 minutes2

Timely pain reduction

DSUVIA showed a greater pain intensity difference to baseline vs placebo (P=0.002) at 15 minutes, the first assessment.1*

Distribution

Sublingual formulation lowers peak plasma concentration (Cmax) and
extends plasma half-time (Cmax to 50% of Cmax) compared to IV administration.1,3,4

after 1 dose4,5 cmax cmax to 50% of Cmax
Sublingual sufentanil (30 mcg) 63 pg/mL 2.5 h
IV sufentanil (30 mcg) 1074 pg/mL 0.2 h
after 1 dose4,5 cmax
Sublingual sufentanil (30 mcg) 63 pg/mL
IV sufentanil (30 mcg) 1074 pg/mL
after 1 dose4,5 cmax to 50% of Cmax
Sublingual sufentanil (30 mcg) 2.5 h
IV sufentanil (30 mcg) 0.2 h
Extended redosing interval

DSUVIA showed an average of 3 hours between doses over a 12-hour period, with a minimum redosing interval of 1 hour.1*

*The pivotal trial evaluated the efficacy and safety of DSUVIA in 161 post-operative abdominal surgery patients. The primary endpoint was time-weighted summed pain intensity difference to baseline over 12 hours (SPID12). A secondary endpoint was pain intensity difference to baseline at each evaluation time point. Redosing interval (time between doses) was also recorded.1,3

Patients may require more frequent redosing (minimum interval 1 hour) than the 3-hour average when initiating DSUVIA.3

DSUVIA provides a balance of onset and duration with 1 dose4

Plasma concentrations of sublingual sufentanil reached the analgesic threshold by 30 minutes and stayed above threshold for approximately 3 hours.4

Plasma Concentration (Cp) Profile of Sublingual Sufentanil After 1 Dose3‑5
Chart: Plasma concentration (Cp) profile of sublingual sufentanil after 1 dose Chart: Plasma concentration (Cp) profile of sublingual sufentanil after 1 dose

*The minimum median effective concentration of sufentanil (24 pg/mL) was demonstrated by Lehmann et al.6

study design
A pharmacokinetics study evaluated plasma concentrations (Cp) of sublingual sufentanil in 122 healthy subjects. After 1 dose (n=39), Cp exceeded 30 pg/mL at 30 minutes; by 180 minutes after administration, Cp decreased to ˜30 pg/mL. The pharmacokinetics study also evaluated clearance of sublingual sufentanil in 944 patients. Patients showed small increases in clearance with an increase in weight, and small decreases in clearance with an increase in age. Clearance was not significantly affected by sex, race, or mild-to-moderate renal impairment.3,4

More information on DSUVIA
 
Safety Profile

Read about the most
common adverse
reactions
with DSUVIA and see
special precautions

 
 
Case Studies:
Emergency Department

See which types of patients
with trauma or injury may
be right for DSUVIA

 
 
Case Studies:
Recovery Room

See which types of
post-operative patients
may be right for DSUVIA

 
References:
  1. Minkowitz HS, Leiman D, Melson T, Singla N, DiDonato KP, Palmer PP. Sufentanil sublingual tablet 30 mcg for the management of pain following abdominal surgery: a randomized, placebo-controlled, phase-3 study. Pain Pract. 2017;17(7):848-858.
  2. Scott JC, Cooke JE, Stanski DR. Electroencephalographic quantitation of opioid effect: comparative pharmacodynamics of fentanyl and sufentanil. Anesthesiology. 1991;74(1):34-42.
  3. DSUVIA [package insert]. Redwood City, CA: AcelRx Pharmaceuticals, Inc; 2018.
  4. Fisher DM, Chang P, Wada DR, Dahan A, Palmer PP. Pharmacokinetic properties of a sufentanil sublingual tablet intended to treat acute pain. Anesthesiology. 2018;128(5):943-952.
  5. Data on file. AcelRx Pharmaceuticals, Inc.
  6. Lehmann KA, Gerhard A, Horrichs-Haermeyer G, Grond S, Zech D. Postoperative patient-controlled analgesia with sufentanil: analgesic efficacy and minimum effective concentrations. Acta Anaesthesiol Scand. 1991;35(3):221-226.
IMPORTANT SAFETY INFORMATION

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

Accidental Exposure and DSUVIA Risk Evaluation and Mitigation Strategy (REMS) Program

Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, DSUVIA is only available through a restricted program called the DSUVIA REMS Program.

  • 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.

Indications and Usage

DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use:

  • 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.

Contraindications

Use of 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
  • Known hypersensitivity to sufentanil or components of DSUVIA.

Warnings and Precautions

  • Accidental ingestion or exposure to even one dose of DSUVIA, especially in children, can result in respiratory depression and death due to an overdose of sufentanil.
  • DSUVIA is for use in adult patients only in a certified medically supervised healthcare setting. Use of DSUVIA outside of this setting can increase the risk of accidental exposure in others for whom it is not prescribed, causing fatal respiratory depression. Discontinue use of DSUVIA prior to discharge or transfer from the certified medically supervised healthcare setting. DSUVIA is not for home or pediatric use.
  • DSUVIA contains sufentanil, a Schedule II controlled substance. As an opioid, DSUVIA exposes users to the risks of addiction, abuse, and misuse.
  • Profound sedation, respiratory depression, coma, and death may result from the concomitant use of DSUVIA with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
  • Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic and debilitated patients: monitor patients closely, particularly when initiating DSUVIA therapy and when DSUVIA is used with other drugs that depress respiration. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.
  • A potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue DSUVIA if serotonin syndrome is suspected. Cases of adrenal insufficiency have been reported with opioid use (usually > 1 month). Presentation and symptoms are non-specific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Confirm diagnosis with testing as soon as possible and, if confirmed, treat with physiologic replacement of corticosteroids and wean patient from opioid.
  • As with all opioids, sufentanil may produce bradycardia or hypotension in some patients. Therefore DSUVIA should be used with caution in patients with bradyarrhythmias or hypovolemia.
  • DSUVIA should not be used in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure, impaired consciousness or coma.
  • Prolonged use of DSUVIA during pregnancy can result in withdrawal in the neonate, which can be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of this risk and ensure that appropriate treatment will be available.
  • Insufficient data are available on the use of DSUVIA in patients with severe liver or kidney impairment. DSUVIA should be used with caution in such patients due to the importance of these organs in the metabolism and excretion of sufentanil.

Adverse Reactions

Adverse reactions are described, or described in greater detail, in other sections of the Prescribing Information:

  • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3)]
  • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.4)]
  • Adrenal Insufficiency [see Warnings and Precautions (5.9)]
  • Severe hypotension [see Warnings and Precautions (5.10)]
  • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)]
  • Seizures [see Warnings and Precautions (5.13)]
  • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.15)]

The most commonly reported adverse reactions (≥ 2% and higher than placebo) were nausea, headache, vomiting, dizziness, and hypotension.

Medical Information

For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact the AcelRx Medical Information Contact Center at 1-855-925-8476 or AcelRxMedInfo@rmpdc.org.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Directions For Use.

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