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FDA Approves Opioid Agonist for Intravenous Use in Hospitals

Oct, 2020

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The most common side effects of Olinvyk (an opioid agonist) are constipation, headache, dizziness, vomiting, and nausea.

On August 7, the United States Food and Drug Administration (FDA) approved an opioid agonist (Olinvyk) for the management of moderate to severe acute pain in adults, where the pain requires an intravenous opioid. Olinvyk is pointed out for short-term intravenous use in clinical settings such as during outpatient and inpatient procedures. Olinvyk is not indicated for home use. An agonist is a drug that activates certain receptors in the brain and full opioid agonists activate the brain’s opioid receptors fully resulting in the full opioid effect. Examples of full agonists are opium, morphine, hydrocodone, methadone, oxycodone, heroin, and others.

During randomized control trials, the team recruited around 1,535 individuals with moderate to severe acute pain and treated them in open-label controlled and trials with Olinvyk. However, the participants were divided into two groups such as the Olinvyk group and the placebo group. The team then examined the safety and effectiveness of the Olinvyk by comparing it to placebo in controlled studies in those who had experienced abdominal surgery or bunion surgery. The researchers found that the participants administered with an approved dose of Olinvyk reported a decrease in acute pain in comparison to the placebo group.

The most common side effects of Olinvyk are constipation, headache, dizziness, vomiting, and nausea. Olinvyk is not indicated for those with respiratory depression. Continuous use of opioid analgesics during pregnancy may result in a neonatal opioid withdrawal syndrome. Moreover, Olinvyk gives a boxed warning about intoxication, misuse and abuse, risks from concomitant use with benzodiazepines, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. The maximum daily dose limit of Olinvyk is 27 mg. The FDA has granted approval of Olinvyk to the U.S. based pharmaceutical company, Trevena.

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