IV oliceridine

Moderate-to-Severe Acute Pain

Intravenous (IV) opioids are an important treatment option for millions of hospital patients, with over 45 million patients estimated to receive this type of analgesic each year.1 For surgeries where severe, prolonged, or deep/visceral pain is expected, IV opioids are considered an essential component of a patient’s pain management regimen. The number of these complex and painful procedures is increasing, representing a growing burden on hospital systems.2 However, drugs like IV morphine have limitations, including adverse effects such as nausea, vomiting, and respiratory depression, all of which can negatively impact a patient’s recovery.3,4,5

There remains a significant clinical need for an effective and well-tolerated IV analgesic, particularly for patients who are more susceptible to these dose-limiting adverse effects, such as those who are elderly, obese, or renally-impaired. Current hospital trends suggest that the number of these high-risk patients is growing.7,8

About IV oliceridine

Trevena’s lead product candidate, oliceridine injection, is a first-in-class IV analgesic in development for the management of moderate to severe acute pain. Oliceridine is the first G protein-selective agonist and was designed to deliver an improved analgesic profile compared to IV morphine. It targets the mu-opioid receptor with an optimized mechanism of action (MOA) that preferentially engages the signaling pathway responsible for efficacy, with reduced activation of the signaling pathway responsible for adverse effects.

Program Molecular Target Therapeutic Target Current Phase PC PH1 PH2 PH3 NDA
Oliceridine Mu receptor Moderate-to-severe acute pain NDA Intravenous PC complete PH1 complete PH2 complete PH3 complete NDA in progress
Oliceridine is an Investigational Product not approved by FDA for sale or distribution in the US.
  1. IMS charge detail master hospital cost database, FY 2017 data.
  2. SG2 Healthcare Intelligence.
  3. Cashman and Dolin, Respiratory and hemodynamic effects of acute postoperative pain management; BJA 93 (2): 212–23 (2004).
  4. American Society for Pain Management Nursing Guidelines on Monitoring for Opioid-induced Sedation and Respiratory Depression, PMN, Vol 12, No.3; 2011.
  5. Gan et al, Consensus Guidelines for the Management of Postoperative Nausea and Vomiting, Anesth. Analg. 2014;118(1):85-113.
  6. Icons made by Freepik from www.flaticon.com.
  7. CDC, National Hospital Discharge Survey 2010.
  8. ARHQ HCUP statistical brief #137.