Oliceridine

Source: Wikipedia, the free encyclopedia.
Oliceridine
Clinical data
PronunciationOH li SER i deen
Trade namesOlinvyk
Other namesTRV-130, TRV130
AHFS/Drugs.comProfessional Drug Facts
License data
Routes of
administration		Intravenous[1]
ATC code
Legal status
Legal status
Identifiers
  • N-[(3-Methoxythiophen-2-yl)methyl]-2-[(9R)-9-pyridin-2-yl-6-oxaspiro[4.5]decan-9-yl]ethanamine
JSmol)
  • COc1ccsc1CNCC[C@]2(CCOC3(CCCC3)C2)c4ccccn4
  • InChI=1S/C22H30N2O2S/c1-25-18-7-15-27-19(18)16-23-13-10-21(20-6-2-5-12-24-20)11-14-26-22(17-21)8-3-4-9-22/h2,5-7,12,15,23H,3-4,8-11,13-14,16-17H2,1H3/t21-/m1/s1
  • Key:DMNOVGJWPASQDL-OAQYLSRUSA-N

Oliceridine, sold under the brand name Olinvyk, is an opioid medication that is used for the treatment of moderate to severe acute pain in adults.[3] It is given by intravenous (IV) injection.[3]

The most common side effects include nausea, vomiting, dizziness, headache, constipation, itchy skin and low oxygen levels in blood.[4]

It was approved for medical use in the United States in August 2020.[4]

Medical uses

Oliceridine is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.[3] It is not indicated for at-home use.[3]

Adverse effects

The safety profile of oliceridine is similar to other opioids.[3] As with other opioids, the most common side effects of oliceridine are nausea, vomiting, dizziness, headache and constipation.[3] Prolonged use of opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome.[3]

Olinvyk carries a boxed warning about addiction, abuse and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other central nervous system depressants.[3] Unlike other opioids for intravenous administration, Olinvyk has a maximum recommended daily dose limit of 27 milligrams.[3]

Contraindications

Oliceridine should not be given to people 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; or known hypersensitivity to the medication.[3]

Pharmacology

Pharmacodynamics

Oliceridine is a

receptor internalization.[5] It has been suggested that this might be due to its low intrinsic efficacy,[6] rather than functional selectivity or 'G protein bias', although the validity of that conclusion has also been questioned.[7] In vivo, it may have fewer adverse effects (including respiratory depression and constipation) compared with morphine.[8][9][10] In general, in vitro potency does not guarantee any clinical relevance in humans.[11]

History

A total of 1,535 participants with moderate to severe acute pain were treated with oliceridine in controlled and open-label trials.[3] Its safety and efficacy were established by comparing oliceridine to placebo in randomized, controlled studies of participants who had undergone bunion surgery or abdominal surgery.[3] Participants administered oliceridine reported decreased pain compared to placebo at the approved doses.[3]

The U.S. Food and Drug Administration (FDA) approved oliceridine based on evidence from three clinical trials (Trial 1/NCT02815709, Trial 2/NCT02820324 and Trial 3) of 1558 participants 18 to 89 years old who were in need of pain medication.[4] The trials were conducted at 53 sites in the United States.[4]

Trial 1 enrolled participants who underwent bunion surgery.[4] Participants with moderate to severe post-surgical pain were randomly assigned to receive oliceridine, placebo or an approved drug to treat pain (morphine) for 48 hours intravenously.[4] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed.[4] All participants were allowed to use a rescue pain medication, if the pain was not well controlled using the trial medications.[4]

Trial 2 enrolled participants who underwent surgical removal of abdominal wall fat (abdominoplasty) and had moderate to severe pain.[4] Participants were randomly assigned to receive oliceridine, placebo or an approved drug to treat pain (morphine) for 24 hours intravenously.[4] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed.[4] All participants were allowed to use a rescue pain medication, if the pain was not well controlled using the trial medications.[4]

To assess the benefits of oliceridine, participants used a numerical scale to score how severe the pain was after the surgery.[4] The scores for the participants receiving oliceridine were compared to the scores for the participants who received placebo and those who received morphine.[4]

In the third trial, participants who had pain following various type of surgeries or due to a medical condition received at least one dose of oliceridine.[4] Data from this trial were used only to assess the side effects of oliceridine.[4]

Oliceridine was approved for medical use in the United States in August 2020.[3] The FDA granted approval of Olinvyk to Trevena Inc.[3]

Society and culture

Legal status

An advisory committee of the U.S.

ECG, and depression of the respiratory drive (which could cause a person to stop breathing).[12] As a result of the committee's vote, the FDA declined to approve oliceridine, citing safety concerns.[13][14]

Oliceridine was approved for medical use in the United States in August 2020.[3] The FDA granted approval of Olinvyk to Trevena Inc.[3]

The DEA issued an interim final rule on October 30, 2020, designating oliceridine as CSA Schedule II (DEA Code 9245).[full citation needed]

See also

References

  1. ^ "Olinvyk- oliceridine injection, solution". DailyMed. 18 August 2020. Retrieved 16 September 2020.
  2. FDA
    . Retrieved 22 Oct 2023.
  3. ^ a b c d e f g h i j k l m n o p q "FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings". U.S. Food and Drug Administration (FDA) (Press release). 7 August 2020. Retrieved 7 August 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ a b c d e f g h i j k l m n o p "Drug Trials Snapshots: Olinvyk". U.S. Food and Drug Administration (FDA). 7 August 2020. Retrieved 16 September 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  5. S2CID 8785003
    .
  6. S2CID 214771721
    .
  7. PMID 34468132
    .
  8. PMID 24063433
    .
  9. S2CID 25049515
    .
  10. Genetic Engineering & Biotechnology News
    (Paper). 35 (17): 40.
  11. PMID 12141724
    .
  12. ^ "FDA Panel Votes Against Analgesic Oliceridine". www.medpagetoday.com. MedPage Today, LLC. 11 October 2018. Retrieved 23 December 2018.
  13. ^ "FDA rejects Trevena's painkiller oliceridine | FierceBiotech". www.fiercebiotech.com. Questex LLC. 5 November 2018. Retrieved 23 December 2018.
  14. S2CID 128360210
    .

External links

  • "Oliceridine". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT02815709 for "Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy (APOLLO-1)" at ClinicalTrials.gov
  • Clinical trial number NCT02820324 for "Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty" at ClinicalTrials.gov
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