FDA’s Approves a Drug to Reverse Effects of Deep Paralysis Caused Due To Muscle Relaxants
On Tuesday, the Food and Drug Administration (FDA) gave its approval to Merck & Co Inc.'s drug Bridion, used to reverse the effects of muscle relaxants used during surgery by doctors.
The drug genetically known as sugammadex can generate annual sales of $557 million by 2020, according to Thomson and Reuters data.
According to experts, rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscles.
These drugs are used to paralyze the vocal cords to prevent the patient from breathing automatically when a patient has been given an artificial airway or breathing tube, a process called tracheal intubation, said experts.
They can also be used to prevent a patient from moving during surgery while they are receiving general anesthesia.
Sharon Hertz, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said, “Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery”.
Researchers illustrated the safety and efficacy of the drug in a three-phase clinical trial that included around 456 participants. The recovery time of patients in Bridion treatment groups was faster compared to the comparator groups, with most participants recovering within five minutes of routine use of Bridion.
Approval path of Bridion’s was full of hurdles. The drug was originally developed by Organon BioSciences, which was acquired by Schering-Plough in 2007. And later the drug was acquired by Merck, when it bought Schering-Plough in 2009.
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