FDA approves new IV opioid - Oliceridine (brand name Olinvyk)

This forum made possible through the generous support of SDN members, donors, and sponsors. Thank you.
I'm struggling to figure out why in the world we need another IV opioid without there being some significant benefit compared to fentanyl and dilaudid. Are there some randomized double blind studies out there showing it is safer and has fewer side effects than what we already use? Is there any hospital planning on ordering this without a bankruptcy wish? Perhaps it's gonna be sold cheap and made up in volume?
 
  • Like
Reactions: 7 users
Members don't see this ad :)
I'm on my pain rotation and our pharmacist was just talking about this today. It'll be in-patient use only for perioperative acute pain. But yes, I'm not sure what the advantages of this will be compared to our other IV opioid options for acute pain.
 
  • Like
Reactions: 1 user
"The efficacy of OLINVYK was established in two randomized, double-blind, placebo- and morphine-controlled studies which enrolled 790 patients with moderate to severe acute pain (pain intensity of ≥4 on a 0-10 numeric rating scale) after orthopedic surgery-bunionectomy or plastic surgery-abdominoplasty.

In each study, patients were randomized to one of three OLINVYK treatment regimens, a placebo-control regimen, or a morphine-control regimen. The loading dose for all OLINVYK treatment regimens was 1.5 mg; demand doses were 0.1, 0.35, or 0.5 mg, according to the assigned treatment group; supplemental doses were 0.75 mg. A lockout interval of 6 minutes was used for all PCA regimens. Etodolac 200 mg was available as rescue medication. Patients using the approved OLINVYK doses of 0.35 and 0.5 mg had a statistically significantly greater SPID-48/24 than patients using placebo."

So it got approved because it reduces pain compared to a placebo. Ridiculous. FDA is such a corrupt organization.
 
  • Like
Reactions: 7 users
There won’t even be a steak at Ruth’s Chris because of COVID.
 
  • Like
Reactions: 4 users
Top