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Helsinn Healthcare SA

HELSINN announces submission of supplemental new drug application for Aloxi® injection in post-operativa nausea and vomiting in USA

Lugano (ots)

HELSINN HEALTHCARE SA, a privately owned Swiss
pharmaceutical group, today announced that a supplemental New Drug
Application (sNDA) for Aloxi® (palonosetron hydrochloride)
Injection for the prevention of post-operative nausea and vomiting
(PONV) has been submitted to the U.S. Food and Drug Administration
(FDA). Aloxi is approved by the FDA for the prevention of acute
nausea and vomiting associated with initial and repeat courses of
moderately and highly emetogenic cancer chemotherapy and for the
prevention of delayed nausea and vomiting associated with initial and
repeat courses of moderately emetogenic cancer chemotherapy.
"The achievement of today's milestone is a testament of the hard
work and dedication of HELSINN HEALTHCARE to explore new uses for
Aloxi" said Riccardo Braglia, Chief Executive Officer of HELSINN. "We
look forward to bringing Aloxi for PONV very soon to the medical
community and to their patients. Our US partner MGI PHARMA is
preparing diligently to achieve successfully this goal in the
shortest time."
This sNDA submission is based on results from two randomized,
multi-center, phase 3 trials conducted to evaluate the safety and
efficacy of three doses of Aloxi compared to placebo for the
prevention of PONV. In these two trials, a total of 1,219 patients
undergoing elective outpatient abdominal or gynecological
laparoscopic surgery (Study PALO-04-06) or elective inpatient
gynecological or breast surgery (Study PALO-04-07) were randomized to
receive one of three single intravenous doses of Aloxi or placebo
prior to administration of anesthesia. Both clinical trials
successfully met the primary efficacy endpoint of complete response,
defined as no emesis or use of rescue medication, for the 0-24 hour
time period following surgery for the selected dose of 0.075 mg. In
addition, both trials achieved the secondary endpoints of complete
response for the 0-48 and 0-72 hour time periods. The incidence,
pattern, and intensity of adverse events were similar among all
treatment groups including placebo, and the most frequently observed
side effects were headache and constipation.
About Post-Operative Nausea and Vomiting (PONV)
Post-operative nausea and vomiting, or PONV, is a common
consequence affecting more than one-third of patients undergoing
anesthetic care and surgical procedures. In the United States, nearly
30 million doses of 5-HT3 receptor antagonists are used annually for
the management of PONV. The primary 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. If not prevented, PONV can result
in delayed discharge from the post-anesthesia care unit (PACU) or
ambulatory surgical center facility, hospital re-admissions and
increased healthcare costs.
About Aloxi® (palonosetron hydrochloride) Injection
Aloxi is approved by the U.S. FDA for the prevention of acute
nausea and vomiting associated with initial and repeat courses of
moderately and highly emetogenic cancer chemotherapy and for the
prevention of delayed nausea and vomiting associated with initial and
repeat courses of moderately emetogenic cancer chemotherapy. Aloxi is
the first and only 5-HT3 receptor antagonist to be indicated for the
prevention of delayed CINV caused by moderately emetogenic cancer
chemotherapy. The most common adverse reactions related to Aloxi were
headache (9%) and constipation (5%). Aloxi is contraindicated in
patients known to have hypersensitivity to the drug or any of its
components. Please see the Aloxi package insert, available
www.mgipharma.com and www.aloxi.com, for important additional
details.
About HELSINN HEALTHCARE
HELSINN HEALTHCARE SA, a privately owned pharmaceutical group with
headquarters in Switzerland, 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.

Contact:

HELSINN HEALTHCARE
Rachid BenHamza, Ph.D.
Phone: +41/91/985'21'21
E-Mail: rbh@helsinn.com

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