MGI Pharma, INC, a biopharmaceutical company focused in oncology and acute care, and its partner Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, jointly 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 randomised, multi-centre phase III 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 gynaecologic or breast surgery. PALO-04-07, along with PALO-04-06, a randomized, multi-centre phase 3 clinical trial conducted to evaluate the safety and efficacy of Aloxi compared to placebo for the prevention of PONV following elective outpatient laproscopic abdominal or gynaecological laproscopic 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 III results of Aloxi in PONV, study PALO-04-07 Results from a randomised, double-blind, multicenter, placebo-controlled phase III 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 undergoing elective inpatient gynaecological 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 or placebo prior to receiving anaesthesia. 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 per cent versus 36 per cent) and 24-72 (70 per cent versus 52 per cent) hour time periods following surgery (p less than 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.
Post-operative nausea and vomiting are common consequences of anaesthetic 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, gynaecological, ear/nose/throat, or optical procedures are at highest risk for PONV.
Aloxi is approved by the US 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 per cent) and constipation (5 per cent). Aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components.