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Study in At-Risk,
Non-Opioid-Tolerant
Patients

DSUVIA demonstrated safety and efficacy in an
open-label, postoperative, special populations study1

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

Study evaluated DSUVIA in a range of postoperative patients with moderate-to-severe acute pain and with mild-to-severe systemic disease1

In an open-label study of special populations (N=140), the safety and efficacy of DSUVIA were demonstrated in postoperative patients (mixed surgery types) 40 years and older, 69% of whom had mild-to-severe systemic disease.1

study design

This multicenter, open-label, single-arm study evaluated the use of DSUVIA in at-risk patient populations. Non-opioid-tolerant patients ≥40 years old undergoing a surgical procedure were eligible, with an emphasis on enrolling patients with comorbidities. Following surgery, patients reporting a pain intensity score ≥4 on the numeric rating scale began treatment. Safety assessments over the 12-hour study period included vital signs, oxygen saturation, adverse events, and use of concomitant medications, as well as plasma concentrations of sufentanil. The primary endpoint was summed pain intensity difference to baseline over 12 hours (SPID12). A secondary endpoint was total pain relief throughout the study.1

Patient Comorbidities1

Hepatic and/or renal impairment 29% Diabetes 16%
Hypertension 34% Hyperlipidemia 15%
Hepatic and/or renal impairment 29%
Diabetes 16%
Hypertension 34%
Hyperlipidemia 15%

Surgery Types1

DSUVIA-treated patients achieved 12 hours of pain relief, and many experienced no adverse events1

Mean pain relief significantly improved from baseline starting at 15 minutes after treatment initiation1

Most common related adverse events (≥2%) for DSUVIA (N=140)1

63% of patients (88/140) did not experience any adverse events1

  • 3% (4/140) of patients discontinued due to an adverse event. Reasons for discontinuation were mild oxygen saturation decrease (2 patients), mild pruritus (1 patient), and mild dizziness (1 patient)1

Adverse events in patients with hepatic and renal impairment

The number and types of adverse events were similar for patients with normal or impaired renal or hepatic function. No patients required naloxone during the 12-hour study period.1

DSUVIA provided pain relief over the entire 12-hour study duration

Mean pain relief significantly improved from baseline starting at 15 minutes after treatment initiation, continued to improve through 2 hours, and then remained relatively stable for the remainder of the 12-hour study period (P<0.001). Pain relief was assessed on a 5-point rating scale (from 0=no relief to 4=complete relief).1
More information on DSUVIA
 
Why Sublingual
Sufentanil?

Understand the
pharmacology of DSUVIA,
the first sublingual
formulation of sufentanil

 
 
Real-World
Evidence:
Opioid Use
and Recovery Time

Learn about preoperative
administration of DSUVIA
for patients receiving
outpatient procedures

 

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, which can occur at any dosage or duration, 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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DSUVIA

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.

Addiction, Abuse, and Misuse

Because the use of 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 reassess all patients regularly for the development of these behaviors or conditions.

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.

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 of DSUVIA and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

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.

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

  • 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.
  • 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.
  • 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.
  • Profound sedation, respiratory depression, coma, and death may result from the concomitant use of DSUVIA with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
  • Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation.
  • A potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue DSUVIA if serotonin syndrome is suspected.
  • 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.
  • 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:

  • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.3)]
  • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.4)]
  • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)]
  • Adrenal Insufficiency [see Warnings and Precautions (5.10)]
  • Severe hypotension [see Warnings and Precautions (5.11)]
  • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13)]
  • Seizures [see Warnings and Precautions (5.14)]
  • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.16)]

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 Vertical Pharmaceuticals, LLC at 1-855-925-8476 or [email protected].

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, including BOXED WARNING and Directions for Use.

References:
  • 1. Hutchins JL, Leiman D, Minkowitz HS, Jove M, DiDonato KP, Palmer PP. An open-label study of sufentanil sublingual tablet 30 mcg in patients with postoperative pain. Pain Med. 2018;19(10):2058-2068.

All individuals depicted are models used for illustrative purposes only.

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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, which can occur at any dosage or duration, 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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DSUVIA

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.

Addiction, Abuse, and Misuse

Because the use of 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 reassess all patients regularly for the development of these behaviors or conditions.

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.

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 of DSUVIA and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

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.