Zur Vor-Weihnachtszeit bei den Klöstern im Klösterreich Straß im Straßertale (ots) - Um die ...
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.
ots Originaltext: HELSINN HEALTHCARE SA
Rachid BenHamza, Ph.D.