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Open-Label Study
in Trauma and
Injury Patients

DSUVIA demonstrated safety and efficacy in
an emergency department setting1

Please see Indications and Usage, Limitations of Use, and Important Safety Information, including BOXED WARNING, below.

DSUVIA was studied in various patients with moderate-to-severe acute pain due to traumatic injuries in the emergency department1

In an open-label emergency department (ED) study (N=76), the safety and efficacy of DSUVIA were demonstrated in a diverse patient population with acute pain due to various types of trauma or injury.1

study design

This multicenter, open-label, single-arm study evaluated the use of DSUVIA in the ED. Non-opioid-tolerant patients ≥18 years old who visited the ED with trauma or injury and reported a pain intensity score ≥4 on the numeric rating scale (0=no pain, 10=worst possible pain) were eligible. Patient-reported pain scores were obtained every 15 minutes over the first hour and then hourly. The single-dose cohort (n=40) was followed up to 2 hours. The multiple-dose cohort (n=36) was followed up to 5 hours and could receive up to 3 additional doses at least 1 hour apart.1

Safety assessments included:

  • Cognitive impairment screening1
  • Vital signs, oxygen saturation, adverse events, use of concomitant medications1

Efficacy endpoints included:

  • Time-weighted summed pain intensity difference to baseline over 1 hour1
  • Pain intensity difference to baseline at each time point1
  • Total doses per patient1

Patient Demographics1 (%)

age   sex   race   BMI  
18-64 years 88 Male 61 Caucasian 59 <30 kg/m2 61
≥65 years 12 Female 39 African American 34 ≥30 kg/m2 39
        Native American 7      

age   sex  
18-64 years 88 Male 61
≥65 years 12 Female 39
       
race   BMI  
Caucasian 59 <30 kg/m2 61
African American 34 ≥30 kg/m2 39
Native American 7      

Trauma Classifications1

Trauma Classifications Trauma Classifications

DSUVIA was not associated with cognitive impairment and provided clinically meaningful analgesia with 1 dose1

Of patients who completed the SIS* cognitive test, 97% (73/75) had either no change in cognition or an improved SIS score from baseline to 1 hour. The remaining 2 patients had a 1-point drop from baseline.1

No patients over 65 years of age had a decrease in cognitive skills.1

97-percent of patients (73/75) show no cognitive impairment with DSUVIA

Adverse events

No patients discontinued due to an adverse event and all adverse events were mild with the exception of 1 event of angina pectoris and 1 event of nausea (both were considered moderate in severity).1

Most Common Related Adverse Events (≥2%) for DSUVIA (N=76)1

Most common adverse events Most common adverse events
79-percent of patients (60/76) did not experience any adverse events

Pain intensity reduction in first hour

One dose of DSUVIA significantly reduced pain intensity compared to baseline at 15 minutes and provided clinically meaningful pain reduction at 20 minutes through at least 1 hour in the combined cohort. Patients had a 36% mean reduction in pain intensity at 1 hour.1

Efficacy in patient subgroups

The study evaluated the pain intensity difference to baseline at 1 hour in demographic subgroups. There were no significant differences in pain intensity reduction based on patient's age, sex, race, or BMI in the combined cohort.1

Although study drug was available at every hour, 75% (27/36) of patients in the multiple-dose cohort required only 1 dose of DSUVIA1

Chart: Emergency department study

*The Six Item Screener (SIS) is used to detect cognitive impairment and generate a SIS score (0-6). A score ≥5 is considered not impaired; a score <5 is considered impaired.1

Two patients experienced transient room-air oxygen desaturations below 95% (88% and 94%) that immediately improved with nasal cannula oxygen.1

Defined as a ≥1.3-point reduction on the numeric rating scale for acute pain in the ED.1

§Difference from baseline, P<0.001.1

SEM=standard error of the mean.

More information on DSUVIA
 
One Applicator
Is One Dose

Learn about the
single-strength dosing
and sublingual
administration of DSUVIA

 
 
Case Studies:
Emergency Department

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

 

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.

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.

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.
  • Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider minimizing the use of DSUVIA and carefully monitor the patient for signs of respiratory depression. (revised per 2019 opioid class labeling).
  • 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@rmpds.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.

Reference:
  • 1. Miner JR, Rafique Z, Minkowitz HS, DiDonato KP, Palmer PP. Sufentanil sublingual tablet 30 mcg for moderate-to-severe acute pain in the ED. Am J Emerg Med. 2018;36(6):954-961.
See more safety information ++

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.

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.