The Food and Drug Administration (FDA) approved the opioid Olinvyk, also known as oliceridine, for managing moderate to severe pain on adults. The intravenous (IV) opioid analgesic is an excellent short-term alternative in acute or inadequate pain treatments.
Olinvyk is a full opioid agonist indicated for short-term IV use in controlled clinical settings and hospitals but not for home use.
Every year, about 45 million patients in American hospitals obtain an IV opioid to treat acute pain. This news comes at the right time, especially for patients who are difficult to treat. Such patients include the renal-impaired, elderly, obese and those experiencing comorbid conditions such as diabetes and sleep apnea.
Besides, present hospital trends indicate the growth in numbers of complex patients signifying a rising burden on healthcare providers.
However, after extensive research, Olinvyk approval becomes the new chemical entity in the IV drug class. The opioid provides a unique profile that manages complex patients with crucial needs in acute pain. Additionally, this opioid doesn’t require dosage adjustments in patients struggling with renal impairment, which consists of a vast population with medical problems.
Dosage
After consuming an initial dose, patients will experience its analgesic effects within two to five minutes. For acute pain, health providers should use the lowest effective dose for the shortest period according to a patient’s treatment goals. Patients should not exceed a cumulative dose of 27 mg per day.
Approval
The FDA approval relied on results from the Phase 3 development program, from clinical and open-label trials. The data involved a total of 1,535 patients with mild to severe acute pain. When compared with placebo patients, reports indicated decreased pains to those who used Olinvyk after abdominal surgery.
Side Effects of Olinvyk
The common side effects are similar to other opioids which include:
- Nausea or vomiting
- Dizziness
- Headache
- Constipation
- Inadequate oxygen levels in tissues
- Itchiness
Important Safety Information of Olinvyk
This opioid has warning information based on the following risks:
- Risks of addiction, abuse, and misuse
Olinvyk exposes users to these three risks, which can result in overdose or death. Therefore, rehabs and health providers should evaluate patients’ risks before prescribing them. Also, they should monitor patients regularly for their behavioral development while using it.
- Life-threatening respiratory depression
Severe or fatal life-threatening depression may arise with Olinvyk use. So doctors should monitor this reaction, especially when initiating or increasing its dosage.
- Neonatal opioid withdrawal syndrome
During pregnancy, extended use of Olinvyk may cause this syndrome, which may become life-threatening if not identified and treated early. Therefore, health providers should advice expectant mothers on this risk, mainly if they use it for extended periods.
- Risks from simultaneous use with benzodiazepines or other CNS anti-depressants
Combining Olinvyk with benzodiazepines, alcohol, or other CNS anti-depressants simultaneously may cause coma, severe sedation, respiratory depression, or even death.
Doctors should only reserve it when other treatment options are inadequate while limiting its minimal dosages. Doctors should also assess patients for signs and symptoms of sedation and respiratory depression.
Limitations of Olinvyk Use
Due to these risks, even at recommended doses, health providers should use Olinvyk only in patients who indicate inadequate analgesic results with alternative pain treatment.
