Reviewed by Michael Gill, B. Sc.
7 Dsuvia Clinical Trials Near Me
Top Cities for Dsuvia Clinical Trials
Image of Dallas in Texas.
Dallas
2Active Trials
Institute for Exercise and Environmental MedicineTop Active Site
Image of Bronx in New York.
Bronx
1Active Trials
Montefiore Medical CenterTop Active Site
Dsuvia Clinical Trials by Phase of Trial
Phase 1 & 2 Dsuvia Clinical Trials
1Active Dsuvia Clinical Trials
1Number of Unique Treatments
2Number of Active Locations
Most Recent Dsuvia Clinical Trials

What are Dsuvia Clinical Trials?

Dsuvia is the brand name for sufentanil tablets, synthetic opioids given to hospitalized patients for short-term relief of severe pain. Available by prescription only, the FDA approved it in 2018 for patients who could not use or are unaffected by non-opioid pain medication. Made by AcelRx Pharmaceuticals, Dsuvia is 10 times more effective than fentanyl and 500 times stronger than morphine, making it the most potent opioid painkiller currently available for humans.

Dsuvia is categorized as a controlled medication because it is highly addictive and can lead to abuse and dependency. Therefore its use is monitored closely by healthcare providers. Possible side effects of Dsuvia include headaches, nausea, vomiting, dizziness, and low blood pressure. If administered incorrectly, Dsuvia can lead to respiratory depression, where breathing slows down to the extent that it results in respiratory arrest.

Why Is Dsuvia Being Studied In Clinical Trials?

A tablet form of sufentanil was developed and fast-tracked through FDA approval for military use in the field, where intravenous pain relief was challenging. This decision was greatly criticized by many who believed making such an addictive drug available was a threat to public health.

Statistical data shows that prescription opioid-related overdose deaths continue to rise steadily, from 14,139 (2019) to 16,416 (2020). This data is one reason healthcare professionals are reluctant to introduce new prescription opioids to the market.

Many researchers have voiced hesitation regarding the use of Dsuvia, given its life-threatening side effects. More research is required to compare its effectiveness and safety with other prescription opioids currently available.

How Does Dsuvia Treatment Work?

Dsuvia can only be given under the supervision of a healthcare professional qualified to administer it and trained in airway management. Patients are not allowed to handle the medication; tablets are given by the trained provider directly in the mouth, under the tongue.

A typical dose is 30 mcg (one tablet) given every hour, with a maximum of 12 tablets given in 24 hours. Dsuvia is not given for more than 72 hours, and the medication is stopped once patients are discharged from the hospital.

If a patient begins to show signs of overdose, such as extremely slow breathing (respiratory depression), healthcare providers must reverse the effects by administering naloxone. Sold under the brand name Narcan, naloxone is an accepted antidote for all opioid-based drugs. It can increase breathing as well as eliminate the effects of Dsuvia.

What Are Some of the Breakthrough Clinical Trials Involving Dsuvia?

2022: A clinical trial sponsored by the Cleveland Clinic studies the effects of 30 mcg of sufentanil given to patients after knee surgery with a control group given 50 mcg of fentanyl. The outcomes of this trial are to measure the total amount of fentanyl used during hospitalization as well as the pain score and postoperative nausea and subsequent vomiting.

2022: A clinical trial was done in collaboration with the US Department of Defense to research the effectiveness of Dsuvia in relieving pain in injured patients with moderate to severe pain. Results are measured against a control group that is given standard pain management.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References1 Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. https://pubmed.ncbi.nlm.nih.gov/146227702 Degenhardt L, Bucello C, Mathers B, Briegleb C, Ali H, Hickman M, McLaren J. Mortality among regular or dependent users of heroin and other opioids: a systematic review and meta-analysis of cohort studies. Addiction. 2011 Jan;106(1):32-51. doi: 10.1111/j.1360-0443.2010.03140.x. Epub 2010 Nov 4. Review. https://pubmed.ncbi.nlm.nih.gov/210546133 Jove M, Griffin DW, Minkowitz HS, Ben-David B, Evashenk MA, Palmer PP. Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty: A Randomized, Placebo-controlled Study. Anesthesiology. 2015 Aug;123(2):434-43. doi: 10.1097/ALN.0000000000000746. https://pubmed.ncbi.nlm.nih.gov/260798014 Hansen HB, Siegel CE, Case BG, Bertollo DN, DiRocco D, Galanter M. Variation in use of buprenorphine and methadone treatment by racial, ethnic, and income characteristics of residential social areas in New York City. J Behav Health Serv Res. 2013 Jul;40(3):367-77. doi: 10.1007/s11414-013-9341-3. https://pubmed.ncbi.nlm.nih.gov/237026115 Heel RC, Brogden RN, Speight TM, Avery GS. Buprenorphine: a review of its pharmacological properties and therapeutic efficacy. Drugs. 1979 Feb;17(2):81-110. Review. https://pubmed.ncbi.nlm.nih.gov/3786456 Roberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. Review. https://pubmed.ncbi.nlm.nih.gov/159576877 Ringold FG, Minkowitz HS, Gan TJ, Aqua KA, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):22-30. doi: 10.1097/AAP.0000000000000152. https://pubmed.ncbi.nlm.nih.gov/253184088 Felden L, Walter C, Harder S, Treede RD, Kayser H, Drover D, Geisslinger G, Lötsch J. Comparative clinical effects of hydromorphone and morphine: a meta-analysis. Br J Anaesth. 2011 Sep;107(3):319-28. doi: 10.1093/bja/aer200. Epub 2011 Aug 5. https://pubmed.ncbi.nlm.nih.gov/218410499 Johnson RE, Fudala PJ, Payne R. Buprenorphine: considerations for pain management. J Pain Symptom Manage. 2005 Mar;29(3):297-326. Review. https://pubmed.ncbi.nlm.nih.gov/1578118010 Bernstein MH, Beaudoin FL, Magill M. Response to FDA Commissioner's statement on Dsuvia approval. Addiction. 2019 Apr;114(4):757-758. doi: 10.1111/add.14539. Epub 2019 Jan 20. https://pubmed.ncbi.nlm.nih.gov/30589478