Painkillers! FDA approves o tablet agonist Olinvyk, which works for 2-5 minutes and lasts 3 hours, more effective than morphine!

August 09, 2020 // -- The U.S. Food and Drug Administration (FDA) recently approved an o tablet agitant, Olinvyk, to treat moderate to severe acute pain in adults, specifically in patients who require intravenous opioids, alternative therapies that do not adequately control pain.
Olinvyk is an acute pain treatment drug developed by Trevena for short-term intravenous use in hospitals or other controlled clinical settings, such as inpatient and outpatient procedures.
the drug is not intended for use in a home environment.
Olinvyk's active drug ingredient is olicridine, a pioneering (first-in-class) intravenous analgesic.
is the first G-protein selective agonist, and the analgesic effect is better than intravenous morphine.
olicridine, which targets opioid receptors, prioritizes participation in the signaling path that is responsible for efficacy through an optimal mechanism of action (MOA) to reduce the activation of the signaling path that causes adverse reactions.
Olinvyk has unique, differentiated pharmacogenic dynamics (PK) characteristics: (1) quick and long-lasting efficacy, most patients feel pain relief 2-5 minutes after treatment, the effect lasts about 3 hours.
(2) there is no known active metabolism, and (3) in elderly patients or patients with impaired renal function, no dose adjustment is required, which will provide a new option for at-risk patients.
the opioid crisis remains the FDA's top priority," said Douglas Throckmorton, deputy director of the FDA's Drug Evaluation and Research Center's regulatory program.
we will continue to do everything we can to reduce the number of Americans addicted to opioids and reduce the rate of new addictions through a series of cross-agency initiatives.
importantly, after a rigorous review to assess risks and benefits and ultimately determine data to support safety and effectiveness, the FDA will only approve new drug applications, including opioid applications.
noteworthy that this particular drug is used only in controlled clinical environments, i.e. under medical supervision, and not for home-taking prescriptions.
" In controlled and open-label trials, a total of 1,535 patients with moderate to severe acute pain received Olinvyk treatment.
safety and effectiveness of Olinvyk was determined by comparing placebos in randomized controlled studies in patients who underwent Bunion surgery or abdominal surgery.
data showed that patients with oral Olinvyk had effective pain relief at approved doses compared to the placebo group.
the safety of Olinvyk is similar to that of other opioids.
other opioids, the most common side effects of Olinvyk are nausea, vomiting, dizziness, headaches, and constipation.
should not use Olinvyk in patients with acute or severe bronchial asthma, known or suspected gastrointestinal obstruction, or drug allergy to severe respiratory suppression, unsuppressive or non-resuscitation equipment.
long-term use of opioid analgesics during pregnancy can lead to neonatal opioid withdrawal syndrome.
Olinvyk carries a black-boxed warning about: addiction, abuse and misuse, life-threatening respiratory suppression, neonatal opioid withdrawal syndrome, and risk of combination with benzodiazepines or other central nervous system inhibitors.
other opioids given intravenously, the maximum daily dose recommended by Olinvyk is 27 mg.
() Source: FDA Approves New Opioids ForTravenous Use in Hospitals, Other Other Controlled Clinical Settings.