FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation

Monday, December 15, 2008 General News
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WOODCLIFF LAKE, N.J., Dec. 14 Eisai Corporation of NorthAmerica today announced that the U.S. Food and Drug Administration (FDA) hasapproved LUSEDRA(TM) (fospropofol disodium) Injection, an intravenoussedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adultpatients undergoing diagnostic or therapeutic procedures.

In the approval, the FDA required that LUSEDRA be used only by personstrained in the administration of general anesthesia and that all patientsshould be continuously monitored by persons not involved in the conduct of theprocedure.

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

"We are pleased with the FDA's decision to approve Lusedra, as it providesa 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 unmetneeds of patients."

The FDA has recommended that LUSEDRA be classified as a controlledsubstance. A final scheduling decision is expected from the U.S. DrugEnforcement Administration (DEA) after publishing a proposed rule in theFederal Register and allowing for public comment. Once LUSEDRA receives finalscheduling designation, the label will be amended.

About LUSEDRA(TM) (fospropofol disodium) Injection

LUSEDRA(TM) (fospropofol disodium) Injection is a proprietarywater-soluble prodrug of propofol that, after intravenous injection, isconverted by alkaline phosphatase enzymes in the body into propofol. LUSEDRAis an intravenous sedative-hypnotic agent indicated for monitored anesthesiacare (MAC) sedation in adult patients undergoing diagnostic or therapeuticprocedures.

Important Safety Information

LUSEDRA should be administered only by persons trained in theadministration of general anesthesia and not involved in the conduct of thediagnostic or therapeutic procedure. Patients should be continuously monitoredduring sedation and through the recovery process for early signs ofhypotension, apnea, airway obstruction, and/or oxygen desaturation. Facilitiesfor providing cardiopulmonary resuscitation must be immediately available.

The following serious adverse reactions have been reported with the use ofLUSEDRA.

The use of supplemental oxygen is recommended in all patients receivingLUSEDRA. Airway assistance maneuvers may be required. As with othersedative-hypnotic agents, LUSEDRA may produce additive cardio-respiratoryeffects when administered with other cardio-respiratory depressants such asbenzodiazepines and narcotic analgesics. When LUSEDRA is used at greater thanthe recommended doses, the incidence of serious adverse reactions isincreased.

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

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of EisaiCo., Ltd., a research-based human health care (hhc) company that discovers,develops and markets products throughout the world. Eisai focuses its effortsin three therapeutic areas: neurology, gastrointestinal disorders andoncology/critical care.

Eisai Corporation of North America supports the activities of itsoperating companies in North America, which include: Eisai Research Instituteof Boston, Inc., a discovery operation with strong organic chemistrycapabilities; Morphotek, Inc., a biopharmaceutical company specializing in thedevelopment of therapeutic monoclonal antibodies; Eisai Medical Research Inc.,a clinical development group; Eisai Inc., a commercial operation withmanufacturing and marketing/sales functions; and Eisai Machinery U.S.A., whichmarkets and maintains pharmaceutical manufacturing machinery. For moreinformation about Eisai, please visit www.eisai.com.

About Eisai Inc.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. that wasestablished in 1995 and is ranked among the top-20 U.S. pharmaceuticalcompanies (based on retail sales). Eisai Inc. began marketing its firstproduct in the United States in 1997 and has rapidly grown to become anintegrated pharmaceutical business with fiscal year 2007 (year ended March 31,2008) sales of approximately $3 billion, including the results of theacquisition of MGI PHARMA, Inc.

Eisai Inc. employs approximately 1,900 people at its headquarters inWoodcliff Lake, NJ, at its state-of-the-art pharmaceutical production andformulation research and development facility in Research Triangle Park, NC,and in the field. For more information about Eisai, please visitwww.eisai.com.-- 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.

SOURCE Eisai Corporation of North America


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