Eisai receives approval for intravenous sedative

Eisai has received approval for its intravenous sedative-hypnotic agent Lusedra (fospropofol disodium), it emerged this week.

The company stated it had been given the green light by the Food and Drug Administration for the product, which was developed for use in monitored anaesthesia care for adults undergoing therapeutic or diagnostic procedures.

A condition of the approval was that Lusedra will only be administered by trained anaesthesia professionals and any patient receiving the treatment would be monitored by an objective outsider.

Eisai president Cynthia Schwalm said the company was “pleased” with the announcement.

“With the approval of Lusedra, Eisai continues to fulfil its human healthcare mission to address the unmet needs of patients,” she added. “It provides a new option for monitored anaesthesia care sedation in adult patients.”

Side effects reported with the product include hypotension, hypoxemia, respiratory depression and loss of purposeful responsiveness.

Eisai USA was established in 1981 and established a research institute in Boston six years later, although the original international business started in 1936.

The North American prescription pharmaceutical sales division of the company was formed in 1995 and a medical sales force followed in 1996.