FDA Approvals, Highlights, and Summaries: Anesthesiology 

February 24, 2021

Olinvyk (oliceridine)

Oliceridine, a mu-opioid receptor agonist, is indicated for management of moderate-to-severe acute pain that is severe enough to require an intravenous opioid and for which alternative treatments are inadequate. (Olinvyk prescribing information)

Byfavo (remimazolam)

Remimazolam is a short-acting benzodiazepine for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

Approval was supported by studies of patients undergoing colonoscopy or bronchoscopy. Patients who received remimazolam had a higher total success rate for each of the procedures (80.6-91.3%) compared with placebo (1.7-4.8%). A lower incidence of rescue sedative medication was taken with remimazolam (3.4-15.8%) compared with placebo (90.5-95%). Additionally, the total amount of fentanyl and midazolam rescue medication needed during the procedure was less with remimazolam compared with placebo. (Byfavo prescribing information)

Barhemsys (amisulpride)

Amisulpride is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist. D2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings. Activation of the CTZ relays stimuli to the vomiting center, which is involved in emesis. It is indicated for prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. It is also indicated for treatment of PONV in adults who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

In a randomized, double-blind, placebo-controlled study involving patients in whom the most commonly used antiemetic prophylaxis had failed, a single 10-mg dose of amisulpride (n=230) was significantly more effective than placebo (n=235) at treating patients (42% vs 29%; P=.003). ( Anesthesiology. 2019;130(2):203-212)

In a randomized, double-blind, placebo-controlled trial for patients at the highest risk of developing PONV (Apfel score 3 or 4), a single 5-mg dose of amisulpride in combination with another antiemetic (n=572) significantly improved protection from PONV compared with placebo plus another antiemetic (n=575; 58% vs 47%; P <.001). Anesthesiology. 2018;128(6):1099-1106

Other notable anesthesiology approval

XaraColl (bupivacaine implant) - New dosage form approved for postsurgical pain after open inguinal hernia surgery

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