MGI Pharma, Inc, a biopharmaceutical company focused in oncology and acute care, and its partner Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, announced that a supplemental New Drug Application (sNDA) for Aloxi (palonosetron hydrochloride) capsules for oral administration has been submitted to the US Food and Drug Administration (FDA).
Aloxi Injection 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 sNDA submission includes results from a multicenter, double-blind, dose ranging trial in 651 patients receiving moderately emetogenic chemotherapy (MEC). Patients were stratified by gender and history of chemotherapy and were randomly assigned to receive one of three doses of oral Aloxi (0.25 mg, 0.50 mg, or 0.75 mg) or a single intravenous (IV) 0.25 mg dose of Aloxi. The primary objective of the study was to determine an oral dose which was non-inferior to the IV 0.25mg dose of Aloxi. Endpoints of the trial included complete response (CR; no emesis, no rescue therapy) at multiple time intervals.
Overall, results of the study indicate that the 0.50 mg oral dose of Aloxi was non-inferior to the 0.25mg IV dose at inducing a CR during both the early (0-24 hr) and delayed phases (0-48, 0-72, 0-120 hr) following administration of MEC. Specifically, CR rates for the 0.50 mg dose of oral Aloxi were 76.3 per cent and 58.8 per cent for the 0-24 hours and 0-120 hours time periods versus 70.4 per cent and 59.3 per cent for the 0.25mg IV dose of Aloxi, respectively.
Adverse events were similar in nature and rate for the oral and IV Aloxi groups and typical for this class of drug (headache and constipation). Results from this trial were presented on September 26, 2007, at the 14th European Cancer Conference.
"The submission of the sNDA for an oral formulation of Aloxi represents another key milestone in the efforts of Helsinn Healthcare and MGI to seek indications that expand the Aloxi label and accelerate the growth of the Aloxi franchise. We believe Aloxi's unique pharmacodynamic profile and long-lasting activity would be desirable in clinical settings where an oral formulation may be preferred ", said Mary Lynne Hedley, executive vice president and chief scientific officer, MGI Pharma.
"We are extremely pleased with this submission as it represents an important step in broadening the Aloxi franchise", said Dr. Sergio Cantoreggi, senior director, Research & Development, Helsinn Healthcare SA. "We believe an oral formulation of Aloxi may offer important benefits to the medical community and cancer patients".
Aloxi (palonosetron hydrochloride) InjectionAloxi 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.
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 (US and Europe).
MGI Pharma, Inc. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops, and commercialises 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.