%u25BA Supplemental Drug Application Submitted for Postoperative Nausea and Vomiting
MGI Pharma and Helsinn announce submission for Aloxi® injection for use in postoperative nausea and vomiting
MGI Pharma Inc., a biopharmaceutical company focused in oncology and acute care, and its partner Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, have announced that a supplemental New Drug Application (sNDA) for Aloxi® (palo¬nosetron hydrochloride) Injection for the prevention of postoperative nausea and vomiting has been submitted to the U.S. Food and Drug Administration (FDA).
Aloxi is a selective serotonin subtype 3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. 5-HT3 receptors are located on the nerve terminals of the vagus nerve in the periphery, and centrally in the chemoreceptor trigger zone of the area postrema. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT3 receptors located on vagal afferent nerves to initiate the vomiting reflex. Currently, Aloxi is indicated for: (1) the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy; and (2) the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
According to Lonnie Moulder, President and Chief Executive Officer of MGI Pharma, “Postoperative nausea and vomiting affects approximately one-third of patients who undergo surgery, and can lead to increased health care costs resulting from delayed discharge from hospitals or ambulatory surgical centers, and hospital re-admissions. Studies have demonstrated an ongoing need for effective long-term agents that can improve the control of both nausea and vomiting post-surgery. The unique pharmacodynamic profile and extended duration of activity of Aloxi may prevent postoperative nausea and vomiting for up to three days with a single dose. We believe this submission is an important step in maximizing the potential of Aloxi.”
The sNDA submission is based on favorable results from two multicenter, randomized, placebo-controlled, Phase III trials conducted to evaluate the safety and efficacy of three doses of Aloxi. In these trials, a total of 1,219 patients undergoing elective outpatient abdominal or gynecological laparoscopic surgery (Study PALO-04-06) or elective inpatient gynecological or breast surgery (Study PALO-04-07) were randomized to receive one of three single intravenous doses of Aloxi or placebo prior to administration of anesthesia. Both clinical trials successfully met the primary efficacy endpoint of complete response, defined as no emesis or use of rescue medication, for the 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 48- and 72-hour postoperative time periods.
Postoperative nausea and vomiting occurs commonly and affects more than one-third of patients undergoing ambulatory and in-patient surgical procedures. In the United States approximately 30 million doses of 5-HT3 receptor antagonists are used annually for the management of postoperative nausea and vomiting. The primary factors that can increase the risk for postoperative nausea and vomiting include female gender, non-smoking status, prior history of postoperative nausea and vomiting or motion sickness, length of surgery, and use of volatile anesthetics and opioids. If not prevented, postoperative nausea and vomiting may result in delayed discharge, hospital re-admission, and increased healthcare costs. – John D. Zoidis, MD
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