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Helsinn Healthcare SA Announces Aloxi sNDA for PONV accepted for review by U.S. FDA
PDUFA date of 4th March 4, 2008 established
Lugano (ots) - Helsinn's Top Management today announced that the supplemental New Drug Application (sNDA) for Aloxi® (palonosetron hydrochloride) Injection for the prevention of post-operative nausea and vomiting was accepted for filing by the United States Food and Drug Administration (FDA). Aloxi 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 for Aloxi Injection was submitted to the FDA on May 7, 2007. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Aloxi Injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by March 4, 2008.
The sNDA included data from two randomized, multi-center, phase 3 trials conducted to evaluate the safety and efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. In these two 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. Data were collected to examine the effectiveness and safety of Aloxi during the time course of patient risk for nausea and vomiting, regardless of inpatient or outpatient site of postoperative care on the day of surgery and for two more days (0-72 hrs). Both clinical trials successfully met the primary efficacy endpoint of complete response, defined as no emesis or use of rescue medication, for the 0-24 hour time period and the key secondary efficacy endpoint of complete response for the entire 0-72 hour time period following surgery, for the proposed dose of 0.075 mg. 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 hospital re-admissions and increased healthcare costs in approximately 58% of patients who undergo surgery.
About Aloxi® Injection
Aloxi is currently being evaluated in a clinical program designed to evaluate its safety and efficacy in post-operative nausea and vomiting, but it is not approved for this indication. 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 chemotherapy-induced nausea and vomiting (CINV) caused by moderately emetogenic cancer chemotherapy. The most common adverse reactions related to Aloxi were headache (9%) and constipation (5%). Please see the Aloxi package insert, available www.mgipharma.com and www.aloxi.com, for important additional details.
About HELSINN HEALTHCARE
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland and 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.
ots Originaltext: Helsinn Healthcare SA
Rachid BenHamza, Ph.D.,