FDA approves Lusedra (fospropofol disodium) injection for monitored anesthesia care sedation

Dec 14 2008

Eisai Corporation of North America today announced that the U.S. Food and Drug Administration (FDA) has approved Lusedra (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

In the approval, the FDA required that Lusedra be used only by persons trained in the administration of general anesthesia and that all patients should be continuously monitored by persons not involved in the conduct of the procedure.

On May 7, 2008, the FDA Advisory Committee on Anesthetic and Life Support Drugs voted 6 to 3 in favor (with one abstention) of approval of Lusedra for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures. The committee recommended use of Lusedra by healthcare providers who are appropriately trained.

"We are pleased with the FDA's decision to approve Lusedra, as it provides a new option for monitored anesthesia care (MAC) sedation in adult patients," said Cynthia Schwalm, President, Eisai Inc. "With the approval of Lusedra, Eisai continues to fulfill its human health care mission to address the unmet needs of patients."

The FDA has recommended that Lusedra be classified as a controlled substance. A final scheduling decision is expected from the U.S. Drug Enforcement Administration (DEA) after publishing a proposed rule in the Federal Register and allowing for public comment. Once Lusedra receives final scheduling designation, the label will be amended.

About Lusedra (fospropofol disodium) Injection

Lusedra (fospropofol disodium) Injection is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase enzymes in the body into propofol. Lusedra is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

Safety Information

Lusedra should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the diagnostic or therapeutic procedure. Patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. Facilities for providing cardiopulmonary resuscitation must be immediately available.

The following serious adverse reactions have been reported with the use of Lusedra:

• Hypotension -- Hypotension was reported in 18/455 (4%) patients treated with Lusedra using the standard or modified dosing regimen. -- Patients with compromised myocardial function, reduced vascular tone, or who have reduced intravascular volume may be at an increased risk for hypotension.
• Hypoxemia -- Hypoxemia was reported in 20/455 (4%) patients treated with Lusedra using the standard or modified dosing regimen. Retention of purposeful responsiveness did not prevent patients from becoming hypoxemic following administration of Lusedra.
• Respiratory depression -- Apnea was reported in 1/455 (< 1%) patients treated with Lusedra using the standard or modified dosing regimen.
• Loss of purposeful responsiveness -- Lusedra has not been studied for use in general anesthesia. However, administration of Lusedra may inadvertently cause patients to become unresponsive or minimally responsive to vigorous tactile or painful stimulation. The incidence of patients who became minimally responsive or unresponsive to vigorous tactile or painful stimulation was 7/183 (4%) for colonoscopy and 24/149 (16%) for bronchoscopy. The duration of minimal or complete unresponsiveness ranged from 2 to 16 minutes in colonoscopy patients and from 2 to 20 minutes in bronchoscopy patients.      

The use of supplemental oxygen is recommended in all patients receiving Lusedra. Airway assistance maneuvers may be required. As with other sedative-hypnotic agents, Lusedra may produce additive cardio-respiratory effects when administered with other cardio-respiratory depressants such as benzodiazepines and narcotic analgesics. When Lusedra is used at greater than the recommended doses, the incidence of serious adverse reactions is increased.

The most common adverse reactions (reported in greater than 20%) are paresthesia and pruritis.