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HELSINN announces positive Phase 3 results for ALOXI® (Palonosetron Hydrochloride) injection for the prevention of post operative nausea & Vomiting
Lugano (ots) - HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today announced the successful completion of two phase 3 trials of Aloxi® (palonosetron hydrochloride) Injection for the prevention of post-operative nausea and vomiting (PONV). Both clinical trials successfully met the primary efficacy endpoint of complete response 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 treatment groups, and the most frequently observed side effects were headache and constipation.
Two randomized, multi-center phase 3 clinical trials were conducted to evaluate the safety and efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. Based on these results, HELSINN and its US partner MGI PHARMA plan for the submission of a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration during the first half of 2007.
"HELSINN is pleased with the completion of the phase 3 trials and we look forward to full presentation of these data at future medical meetings," said Enrico Braglia, Managing Director of HELSINN. "We are enthusiastic about working together with our partner MGI PHARMA to bring this new indication to the medical community and to patients".
About Post-Operative Nausea and Vomiting (PONV)
Post-operative nausea and vomiting, or PONV, is a common consequence of anesthetic and surgical procedures. In the United States, nearly 30 million doses of 5-HT3 receptor antagonists are used annually for the management of PONV. 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. If not prevented, PONV can result in hospital re-admissions and increased healthcare costs in approximately 58% of patients who undergo surgery.
About Aloxi® 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 in USA for the prevention of delayed chemotherapy-induced nausea and vomiting (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. For more information please visit www.aloxi.com.
About HELSINN HEALTHCARE
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.
ots Originaltext: HELSINN HEALTHCARE SA
Rachid BenHamza, Ph.D.,
Head Business Unit Oncology & Supportive Care.