Oral Palonosetron Shows Safe And Effective Control Of Nausea And Vomiting Induced By Multiple Cycles Of Chemotherapy

Date: Oct-02-2012New data presented at the 2012 meeting of the European Society of Medical Oncology
(ESMO) in Vienna show antiemetic efficacy maintained across the chemotherapy cycles and a
positive safety profile

The oral formulation of palonosetron, the second generation 5-HT3 receptor antagonist
(5-HT3 RA), is effective and safe in preventing chemotherapy-induced nausea and vomiting
(CINV) over multiple cycles of moderate emetogenic chemotherapy (MEC), according to the
data presented by Prof Steven Grunberg, Professor of Medicine and Pharmacology, Division
of Hematology and Oncology, University of Vermont, USA, at the ESMO (European Society of
Medical Oncology) Vienna 2012 Congress today.

"Palonosetron, a pharmacologically distinct 5-HT3 RA offers superior CINV prevention
compared with other 5-HT3 RAs when administered as a single intra-venous dose," Prof
Grunberg said. Palonosetron is approved by the European Medicine Agency (EMA) and the US
Food and Drug Administration (FDA) for the prevention of CINV in the intra-venous dosage
of 0.25 mg and in the oral dosage of 0.50 mg, with a demonstrated comparable clinical
effect of the two formulations.

"In our multicenter, open-label study, patients received a single 0.75 mg dose of oral
palonosetron to best evaluate the safety of the oral formulation of multiple cycles of
chemotherapy," prof Grunberg explained.

217 patients, enrolled in 22 study centers in Europe, Mexico and the United States,
received oral palonosetron with or without - at investigator discretion - concomitant
administration of dexamethasone (8 mg on the first day of treatment) 1 hour prior to MEC
for up to a maximum of 4 consecutive cycles. The total number of evaluated cycles was 654;
on average 3 per patient, with about half of the patients receiving 4 cycles.

Antiemetic efficacy was maintained across the chemotherapy cycles with overall
complete response rates (i.e.: no emesis and no need for rescue medication) ranging from
55 to 60% of the patients over the 3-4 cycles.

"The majority of adverse effects were of mild intensity, with headache the most common
one. The few severe, serious adverse effects in the safety profile did not raise clinical
concerns. In conclusion, we can say that oral palonosetron is well tolerated and effective
in preventing CINV over multiple cycles in patients receiving MEC," Prof Grunberg said.

About Chemotherapy-induced nausea and vomiting (CINV)

Chemotherapy-induced nausea and vomiting is among the most dreaded side effects
following therapy in patients with cancer. Despite prophylaxis, on the day of
chemotherapy, up to 30-45 percent of patients experience nausea or vomiting or require
rescue therapy following administration of certain types of emetogenic chemotherapy. The
5-HT3 receptor plays a pivotal role in the process of emesis, and agents that antagonise
these receptor subtypes are the basis for control of this effect. Following the
development of the first generation 5-HT3 receptor antagonists, such as ondansetron and
granisetron, in the late '80s and early '90s, in recent years new compounds have been made
available for preventing CINV, including palonosetron.

About Palonosetron

About Palonosetron (Aloxi(R), Onicit(R), Paloxi(R))

Palonosetron (palonosetron hydrochloride) is a second generation 5-HT3 Receptor
Antagonist, developed for the prevention of chemotherapy-induced nausea and vomiting
(CINV) in patients with cancer, with a long half-life of 40 hours and at least 30 times
higher receptor binding affinity than currently available compounds. Palonosetron
demonstrates, in clinical trials and clinical practice, a unique long-lasting action in
the prevention of CINV. A single intravenous dose of palonosetron provides better
protection from CINV than first-generation 5-HT3 receptor antagonists.

Palonosetron is contraindicated in patients known to have hypersensitivity to the drug
or any of its components. The most commonly reported adverse reactions (incidence greater
than or equal to 2 percent) in CINV trials with palonosetron were headache (9 percent) and
constipation (5 percent), and they were similar to the comparators. Palonosetron has been
developed by the Helsinn Group in Switzerland and today it is marketed as Aloxi(R),
Onicit(R), and Paloxi(R) in more than 60 countries world-wide. Palonosetron, marketed as
Aloxi(R), is the leading brand in the USA within the CINV Day of Chemo segment, and it is
steadily growing in the European markets.

For more information about palonosetron, please visit the website: http://www.aloxi.com

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.