A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure
Condition: Sedation; Anxiety; Pain
Intervention: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03); Placebo NanoTab™
Intervention description: Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™; Single dose of sublingual placebo NanoTab™
Intervention MeSH terms: Sufentanil; Triazolam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: procedural sedation

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of a study medication
      that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This
      drug is being designed to provide mild sedation as well as reduce anxiety and pain before and
      during a procedure (in this case elective abdominal liposuction).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must have provided written informed consent to participate in the study.

          2. Male or female patient between 18 to 60 (inclusive) years of age.

          3. Patient is planning to undergo an elective outpatient abdominal liposuction procedure.

          4. Patient must be classified as American Society of Anesthesiologists (ASA) class I -
             III.

          5. Patient must have Body Mass Index [BMI = weight (kg)/height (m2)] between 20 and 35,
             inclusively.

          6. Female patients of childbearing potential must be using an effective method of birth
             control at the time of the screening visit and for 30 days following the dosing of
             study medication. Acceptable methods of birth control include oral or transdermal
             contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant
             or injection, abstinence, vaginal ring, or sterilization of partner. The reason for
             non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy,
             hysterectomy, or postmenopausal for ≥1 year, must be specified. Patients using
             hormonal forms of contraception must also be willing to use a barrier method of
             contraception from screening through 30 days following the dose of study medication.

          7. Patient is willing to receive antibiotics as per the normal practice of the surgeon.

          8. Patient understands that preoperative analgesics or anxiolytics are not permitted.

          9. Patient is willing to avoid caffeine and alcohol use within 24 hours before the
             procedure.

         10. The patient must be willing and able to understand the study procedures and the use of
             pain and anxiety scales, and to communicate meaningfully with the study personnel.

         11. The patient must have a caregiver available to escort the patient home following the
             procedure.

        Exclusion Criteria:

          1. Patient who is expected to require less than 400 cc or more than 700 cc of abdominal
             fat removal during the procedure.

          2. Patient has previously not responded to opioid analgesics for treatment of pain.

          3. Patient has previously not responded to benzodiazepines for treatment of anxiety.

          4. Patient is currently taking any opioid or has taken any opioid for more than 7
             consecutive days of daily use within the past 3 months prior to the procedure.

          5. Patient is currently taking any benzodiazepine or has taken any benzodiazepine for
             more than 7 consecutive days within the past 3 months prior to the procedure.

          6. Patient is taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14
             days prior to enrolling in the study.

          7. Patient has an allergy or hypersensitivity to opioids.

          8. Patient who is currently taking anti-inflammatory drugs, including steroids.

          9. Use of drugs which are P450 3A4 inducers or inhibitors within 30 days of dosing
             including alprazolam, chlorpheniramine, cimetidine, fluoxetine, haloperidol,
             ketoconazole, itraconazole, erythromycin, clarithromycin, sildenafil, simvastatin, St.
             John's Wort.

         10. Patient who is taking calcium channel blockers or beta blockers.

         11. Patient who will consume grapefruit, or products made with grapefruit, within 3 days
             of study medication dosing.

         12. Patient with a history of chronic obstructive pulmonary disease (COPD) or any other
             respiratory condition or active pulmonary disease.

         13. Patient currently has sleep apnea that has been documented by a sleep laboratory
             study.

         14. Patient is a woman who is pregnant or lactating.

         15. Patient has a history of an anxiety disorder.

         16. Patients with oral mucositis or stomatitis.

         17. Patient has a history of drug, prescription medicine, or alcohol abuse within the past
             2 years.

         18. Patient used an investigational drug or device within 30 days of screening visit.

         19. Patient has undergone a liposuction procedure previously.

         20. Patient has a history of migraine or chronic headache.

         21. Patient who has a positive urine screen for drugs of abuse at screening or on the day
             of procedure.

         22. Patient who has a positive alcohol screen on the day of the procedure.