FDA Grants Priority Review for EMEND, Merck's Investigational Medicine for Prevention of Chemotherapy-Induced Nausea and Vomiting.Business Editors/Health Writers UPPER GWYNEDD, Pa.--(BUSINESS WIRE)--Dec. 6, 2002 Merck & Co., Inc. announced today that the U.S. Food and Drug Administration has assigned a six-month priority review to the company's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for EMEND e·mend tr.v. e·mend·ed, e·mend·ing, e·mends To improve by critical editing: emend a faulty text. (TM)(aprepitant), an investigational Substance P neurokinin-1 (NK-1) receptor antagonist studied in combination with other anti-emetic agents for the prevention of chemotherapy-induced nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. (CINV CINV Chemotherapy Induced Nausea and Vomiting ). Merck's application for EMEND includes results from seven safety and efficacy studies that evaluated this once-daily, oral medicine in combination with other anti-emetic drugs in patients with acute (0 to 24 hours) and delayed (2 to 5 days) nausea and vomiting associated with single and repeated courses of highly emetogenic chemotherapy, including cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic. cis·plat·in n. . Merck researchers have been studying investigational agents that block the binding of Substance P to NK-1 receptors in the brain and gastrointestinal tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract to determine if these agents may inhibit the nausea and vomiting frequently induced by anti-cancer medicines. Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. EMEND(TM) is a registered trademark of Merck & Co., Inc. Platinol(R)-AQ (cisplatin injection) is a registered trademark of Bristol-Myers Squibb Company. This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this document should be evaluated together with the many uncertainties that affect our businesses, particularly those mentioned in the cautionary statements in Item 1 of our Form 10-K for the year ended Dec. 31, 2001, and in our periodic reports on Form 10-Q and Form 8-K (if any) which we incorporate by reference. |
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