FDA Approves Aloxi(R) (Palonosetron HCL) Injection for Prevention of Postoperative...

FDA Approves Aloxi(R) (Palonosetron HCL) Injection for Prevention of
Postoperative Nausea and Vomiting

WOODCLIFF LAKE, N.J., March 2 /PRNewswire/ -- Eisai Corporation of North
America, its U.S. subsidiary, MGI PHARMA, INC., and Helsinn Healthcare SA
today announced that the U.S. Food and Drug Administration (FDA) has approved
Aloxi(R) (palonosetron hydrochloride) injection for the prevention of
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.
Efficacy beyond 24 hours has not been demonstrated.
Aloxi, available in the United States since 2003, is the first and only
5-hydroxytryptamine-3 (5-HT3) receptor antagonist approved by the FDA for the
prevention of acute and delayed nausea and vomiting associated with initial
and repeat courses of moderately emetogenic chemotherapy, and for the
prevention of acute nausea and vomiting associated with initial and repeat
courses of highly emetogenic chemotherapy.
The new indication is based on one double-blind Phase III study that
evaluated the efficacy of three doses of Aloxi compared to placebo for the
prevention of PONV. In the trial, 574 patients undergoing elective gynecologic
or abdominal laparoscopic surgery (predominately in the out-patient setting)
were randomized to receive one of three single intravenous doses of Aloxi
(0.025 mg, 0.050 mg or 0.075 mg) or placebo prior to administration of
anesthesia. The effectiveness of Aloxi in PONV was assessed on the day of
surgery (0-24 hours) and for two subsequent days (24-72 hours).
The trial successfully met its co-primary endpoint of Complete Response
(CR) - defined as no emesis (vomiting) or use of rescue medication - for the
0-24-hour time period (42.8% of patients treated with the approved dose of
Aloxi 0.075 mg experienced a CR, compared to 25.9% of patients given placebo
[p=0.0035]). For the co-primary endpoint of CR for the 24-72-hour
postoperative period, 48.6% of patients treated with Aloxi 0.075 mg
experienced a CR, compared to 40.7% of patients given placebo (p=0.1877, not
significant).
Further, Aloxi 0.075 mg reduced the severity of nausea compared to
placebo, and this was supported by Phase II PONV trial results demonstrating
that Aloxi significantly reduced the severity of nausea compared to placebo
(p=0.009).
The incidence of adverse reactions was indistinguishable among all
treatment groups, including placebo. The most frequently observed side effects
with Aloxi equal to or greater than 2% were electrocardiogram (ECG) QT
prolongation (5%), bradycardia (4%), headache (3%), and constipation (2%).
Included in the updated label with the PONV indication are the results of
a study, in 221 healthy volunteers, on the effects of Aloxi at doses of 0.25
mg, 0.75 mg and 2.25 mg, compared to moxifloxacin, on several ECG intervals, a
potential safety concern of drugs in the 5-HT3 receptor antagonist class. The
study demonstrated that Aloxi had no significant effect on any ECG interval
including QTc duration (cardiac repolarization) at doses up to 2.25 mg.
"These results highlight the unique safety features of Aloxi and when
combined with the clinical results, indicate a favorable risk/benefit ratio,"
said Michael Cullen, M.D., Chief Medical Officer, MGI PHARMA, INC.
"This new indication is in keeping with our human health care mission to
address the unmet medical needs of patients," said Hajime Shimizu, Chairman
and CEO, Eisai Corporation of North America. "A single intravenous dose of
Aloxi can provide anesthesiologists with an effective option for the
prevention of PONV for up to 24 hours."
A recent study indicated that despite the use of multiple prophylactic
agents, 33% of high-risk patients still require rescue therapy during the
first six hours after surgery, and more than 40% suffer symptoms of PONV
severe enough to warrant rescue therapy in the 24 hours after surgery.
An estimated 38 million general anesthesia procedures are performed each
year in the United States (2006 figures), and 39% of these - 15 million
procedures - utilize anti-emetic therapy for PONV. Of these 15 million
procedures, 89%, or 13.4 million, use 5-HT3 receptor antagonists, such as
Aloxi.
"This is an important milestone for Aloxi, given the increasing use of
antiemetic prophylaxis during surgical procedures," said Riccardo Braglia,
CEO, Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group,
holder of the Aloxi New Drug Application and partner of Eisai Corporation of
North America. MGI PHARMA, INC. licensed the North American distribution and
marketing rights for Aloxi from Helsinn.
About Postoperative Nausea and Vomiting (PONV)
Postoperative nausea and vomiting are common consequences of anesthetic
and surgical procedures, and frequently occur following the procedures.
Patients undergoing abdominal, gynecological, ear/nose/throat, or optical
procedures are at highest risk for PONV. Additional factors that can increase
the risk for PONV include female gender, non-smoking status, prior history of
PONV or motion sickness, length of surgery, and the use of volatile
anesthetics and opioids.
About Aloxi(R) Injection
In addition to the new PONV indication, Aloxi (palonosetron HCl) injection
0.25 mg is the first and only 5-HT3 receptor antagonist to be indicated for
the prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of moderately emetogenic chemotherapy, and for the
prevention of acute nausea and vomiting associated with initial and repeat
courses of highly emetogenic chemotherapy.
Aloxi is contraindicated in patients known to have hypersensitivity to the
drug or any of its components. The most commonly reported adverse reactions in
Aloxi chemotherapy-induced nausea and vomiting trials include headache (9%)
and constipation (5%).
Please see the Aloxi package insert, available at www.aloxi.com, for
important additional details.
About HELSINN HEALTHCARE SA
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with
headquarters in Switzerland and is the worldwide licensor of palonosetron.
HELSINN's core business is the licensing of pharmaceuticals in therapeutic
niche areas. The company's business strategy is to in-license early stage new
chemical entities and complete their development from the performance of pre-
clinical/clinical studies and CMC development to the attainment of market
approvals in strategic markets (U.S. and Europe). HELSINN's products are
eventually out-licensed to its marketing partners for distribution. The active
pharmaceutical ingredients and the finished dosage forms are manufactured at
HELSINN's cGMP facilities and supplied worldwide to its customers. For more
information about HELSINN, please visit the company's Web site at
www.helsinn.com.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai
Co., Ltd., a research-based human health care (hhc) company that discovers,
develops and markets products throughout the world. Eisai focuses its efforts
in three therapeutic areas: neurology, gastrointestinal disorders and
oncology/critical care.
Eisai Corporation of North America supports the activities of its
operating companies in North America. These operating companies include: Eisai
Research Institute of Boston, Inc., a discovery operation with strong organic
chemistry capabilities; Morphotek, Inc., a biopharmaceutical company
specializing in the development of therapeutic monoclonal antibodies; Eisai
Medical Research Inc., a clinical development group; Eisai Inc., a commercial
operation with manufacturing and marketing/sales functions; MGI PHARMA, INC.;
and Eisai Machinery U.S.A., which markets and maintains pharmaceutical
manufacturing machinery. For more information about Eisai, please visit
www.eisai.com.
About MGI PHARMA, INC.
MGI PHARMA, INC., a wholly-owned subsidiary of Eisai Corporation of North
America, is a biopharmaceutical company focused in oncology and acute care
that acquires, researches, develops, and commercializes proprietary products
that address the unmet needs of patients. For more information about MGI
PHARMA, INC., please visit www.mgipharma.com.
SOURCE Eisai Corporation of North America

Judee Shuler of Eisai Corporation of North America, +1-201-746-2241