MGI PHARMA and HELSINN Announce Positive Phase 3 Results for Aloxi(R) (Palonosetron Hydrochloride) Injection for the Prevention of Post Operative Nausea & Vomiting
Thursday December 14, 7:01 am ET
Pre-NDA Meeting Held; sNDA Submission Remains on Track for 1H07
MINNEAPOLIS & LUGANO, Switzerland--(BUSINESS WIRE)--MGI PHARMA, INC. (Nasdaq: 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 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 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. 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.
"We and our partner HELSINN are pleased with the results of these phase 3 trials of Aloxi and believe that they describe a product profile with an extended period of activity," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA. "Following our recent pre-NDA meeting with the FDA, we remain on track for the submission of the sNDA for Aloxi in this new indication 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."
Phase 3 Program Design
Two randomized, multi-center phase 3 clinical trials were conducted to evaluate the safety and efficacy of Aloxi compared to placebo for the prevention of PONV following elective outpatient abdominal or gynecological laparoscopic surgery (Study PALO-04-06) or elective inpatient gynecological or breast surgery (Study PALO-04-07). In these two trials, a total of 1,219 patients were randomized to receive one of three single intravenous doses of Aloxi or placebo prior to administration of anesthesia.
The co-primary endpoints of both trials were complete response, defined as no emesis or use of rescue medication, for the 0-24 hour and 24-72 hour time periods following surgery. According to the prospectively defined statistical analysis plan, achievement of the 0-24 hour endpoint determined a successful trial and allowed for the testing of the 24-72 hour endpoint. Secondary endpoints included complete response for both the 0-48 and 0-72 hour time periods, complete control (defined as complete response and no more than mild nausea), number of emetic episodes, incidence and severity of nausea, and impact of PONV on patient functioning.
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. |
