Results of Phase III clinical trial on efficacy and safety of Adamgammadex

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This multicentre, randomised, double-blind, positive-controlled, noninferiority phase III clinical trial aimed to investigate the efficacy and safety of adamagammadex compared with sugammadex in reversing deep rocuronium-induced neuromuscular block. In total, 321 patients were randomly assigned to either the adamgammadex 8 mg kg−1 group or the sugammadex 4 mg kg−1 group. The primary outcome was the success rate of antagonism, defined as recovery of the train-of-four ratio (TOFR) to 0.9 within 10 min. Standard safety data were collected throughout the trial period.

Adamgammadex sodium, manufactured by Hangzhou Adamerck Pharmlabs Inc. (Hangzhou, China), is a modified γ-cyclodextrin derivative. It selectively forms an inactive tight inclusion complex with rocuronium or vecuronium, comprising a lipophilic core and a hydrophilic outer ring.

Based on the primary outcome of rapid reversal of rocuronium-induced neuromuscular block of 1–2 post-tetanic counts (PTCs), adamgammadex (8 mg kg−1) was noninferior to sugammadex (4 mg kg−1).

Adamgammadex is an effective and safe potential clinical alternative to sugammadex.

Bar chart comparing the incidence rates of various adverse effects between adamgammadex (red) and sugammadex (blue) in a clinical trial.

Incidence of adverse effects

  1. Efficacy and safety of adamgammadex for reversing rocuronium-induced deep neuromuscular block: a multicentre, randomised, double-blind, positive-controlled phase III trial.
    Zhao, Yanhua et al.
    British Journal of Anaesthesia, 135(2), 331 – 339

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