Posted by Dantrolene, a ryanodine receptor-1 antagonist, serves as a muscle relaxant primarily used in the treatment of malignant hyperthermia (MH). MH is a severe, life-threatening reaction that can be triggered by certain volatile anaesthetic agents such as halothane, sevoflurane, and desflurane. Symptoms include muscle rigidity, fever, and a rapid heart rate, with the risk of death without proper treatment estimated to be around 70-80%. The fast and easy administration of appropriate medication is crucial in managing this acute and life-threatening condition.
Dantrolene is typically formulated with mannitol and sodium hydroxide. However, on March 21st, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a new medicinal product called Agilus. This new formulation replaces the aforementioned excipients with hydroxypropyl-beta-cyclodextrin (HP-β-CD) and Macrogol 3350.
These changes not only shorten the preparation time but also reduce the volume of water needed to dissolve each vial. Agilus will be available in a higher strength of 120 mg compared to the reference formulation, which contains 20 mg of the active pharmaceutical ingredient.
References:
https://www.ema.europa.eu/en/medicines/human/EPAR/agilus
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4027921
