Aloxi(R) Phase 3 Data for Post Operative Nausea and Vomiting (PONV) Presented at the Annual Meeting of the American Society of Anesthesiologists (ASA)
Monday October 15, 7:01 am ET
Successful Aloxi(R) Phase 3 Results in PONV Presented
MINNEAPOLIS--(BUSINESS WIRE)--MGI PHARMA, INC. (NasdaqGS: MOGN - News), a biopharmaceutical company focused in oncology and acute care, and its partner HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today announced the presentation of results of Study PALO-04-07 at the Annual Meeting of the American Society of Anesthesiologists (ASA). PALO-04-07 is a randomized, multi-center phase 3 clinical trial conducted to evaluate the safety and efficacy of Aloxi® (palonosetron hydrochloride) Injection compared to placebo for the prevention of post-operative nausea and vomiting (PONV) following elective inpatient gynecologic or breast surgery. PALO-04-07, along with PALO-04-06, a randomized, multi-center phase 3 clinical trial conducted to evaluate the safety and efficacy of Aloxi compared to placebo for the prevention of PONV following elective outpatient laparoscopic abdominal or gynecological laparoscopic surgery, served as the basis of a supplemental New Drug Application that was accepted for filing by the Food and Drug Administration on July 9, 2007.
Phase 3 Results of Aloxi in PONV, Study PALO-04-07 (Poster # A52)
Results from a randomized, double-blind, multicenter, placebo-controlled phase 3 study designed to assess the incidence, time course, and treatment patterns associated with PONV and post-discharge nausea and vomiting (PDNV) over three days were reported. Female patients (n=544) undergoing elective inpatient gynecological or breast surgery were stratified for history of PONV and/or motion sickness and were randomly assigned to receive one of three single intravenous doses of Aloxi (0.025mg, 0.05mg, or 0.075mg) or placebo prior to receiving anesthesia. The results show that the study successfully met the primary efficacy endpoint of CR. Complete response rates for the selected dose of Aloxi 0.075 mg were significantly higher than those for placebo during the 0-24 (56% versus 36%) and 24-72 (70% versus 52%) hour time periods following surgery (p < 0.0166). Occurrences of nausea, as measured by a 4-point categorical scale (“none” to “severe”), were less intense in patients who received Aloxi 0.075 mg compared with patients who received placebo in the 0-6 hour, 6-72 hour, and 0-72 hour intervals. 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 are common consequences of anesthetic and surgical procedures, frequently occurring immediately following the procedure and up to 72 hours post procedure. 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 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 at 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.
About MGI PHARMA
MGI PHARMA, INC. 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. MGI PHARMA markets Aloxi® (palonosetron hydrochloride) Injection, Dacogen® (decitabine) for Injection, and Gliadel® Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.<snip> |
