Eisai Inc. today announced that LUSEDRA™ (fospropofol disodium) Injection is now available for use by persons trained in the administration of general anesthesia. LUSEDRA, an aqueous solution, is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. The U.S. Food and Drug Administration (FDA) approved LUSEDRA in December 2008. LUSEDRA is designated as a Schedule IV drug.
"We are pleased to offer the anesthesiology community a new option for their patients undergoing sedation," said Randi Fain, MD, FCCP, Director, Medical Affairs, Oncology and Institutional Care, Eisai Inc. "LUSEDRA will play an important role in the Eisai institutional care portfolio."
Eisai is committed to fulfilling unmet medical needs for patients as part of its human health care mission.
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. There are two dosing regimens for LUSEDRA: standard or modified. Standard dosing regimen is for patients 18 to <65 years of age who are healthy or have mild systemic disease. The modified dosing regimen is for patients who are 65 years of age or older or have severe systemic disease.
Important 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.
-- Respiratory depression -- Apnea was reported in 1/455 (< 1%) patients treated with LUSEDRA using the standard or modified dosing regimen. -- 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. -- 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. -- 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.
The use of supplemental oxygen is recommended in all patients receiving LUSEDRA. Airway assistance maneuvers may be required. LUSEDRA may produce additive cardiorespiratory effects when administered with other cardiorespiratory 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 pruritus.
Please see full prescribing information at www.eisai.com/product.asp?ID=274 .
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2008 (year ended March 31, 2009) sales of approximately $3.7 billion. Eisai Inc.'s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Headquartered in Woodcliff Lake, New Jersey, Eisai Inc. has several R&D facilities in Massachusetts, New Jersey and North Carolina, as well as manufacturing facilities in Maryland and North Carolina. For more information about Eisai, please visit www.eisai.com.
*On October 1, 2009, Eisai Research Institute of Boston, Inc. (established in 1987) and Eisai Medical Research Inc. (established in 2002) were merged into Eisai Inc.
First Call Analyst:
SOURCE: Eisai Inc.
CONTACT: For Media Inquiries: Judee Shuler, Eisai Inc., +1-201-746-2241;
For Investor Inquiries: Bob Laverty, Eisai Inc., +1-201-746-2265
Web Site: http://www.eisai.com/
Type Press Release
Date Released November 16, 2009