Neurex Initiates CORLOPAM Renal Program; Studies Focused on Beneficial Effect on the Kidney.MENLO PARK, Calif.--(BW HealthWire)--Feb. 5, 1997--Neurex Corporation (NASDAQ/NMS:NXCO) today announced that the first study in the CORLOPAM Renal Program has been completed and clinical data analysis is under way. The CORLOPAM Renal Program is a series of small studies designed to characterize the beneficial effects of CORLOPAM on the kidney in order to support a submission for improved labeling claims of the product. The first study, which was completed in January 1997, studied the detailed effects of CORLOPAM on the kidney in healthy human subjects. Future studies will focus on the action of the drug in both hypertensive hypertensive /hy·per·ten·sive/ (-ten´siv) 1. characterized by increased tension or pressure. 2. an agent that causes hypertension. 3. a person with hypertension. patients and patients with compromised renal function. The last study is planned to include patients who are taking drugs such as 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. , that are known to be toxic to the kidney, as well as patients suffering from a variety of diseases that may cause compromised renal function. It will investigate the potential protective effects of CORLOPAM against kidney damage kidney damage Kidney injury Nephrology A structural or functional compromise in renal function due to external–eg, athletic, occupational, or other trauma, resulting in bruising or hemorrhage, which can be profuse and life threatening Etiology Vascular . "Previous studies have demonstrated that CORLOPAM appeared to have a unique profile that not only reduces blood pressure in patients requiring urgent treatment, but at the same time, maintains or improves renal function," said Dr. Paul Goddard, chairman and chief executive officer of Neurex. "This program is designed to focus exclusively on its kidney action and to establish a dose range at which the drug has renal action, without having an effect on blood pressure." The company filed an 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 CORLOPAM in June of 1996. The application seeks approval for intravenous form of the drug to be administered in patients requiring blood pressure control where oral therapy is not feasible or appropriate, such as in patients undergoing cardiovascular surgery cardiovascular surgery Heart surgery An operation for repairing structural defects of the cardiovascular system Examples CABG, repair of congenital heart defects, varicose veins, aortic aneurysms, ventricular remodeling, transmyocardial . CORLOPAM is a dopamine dopamine (dōp`əmēn), one of the intermediate substances in the biosynthesis of epinephrine and norepinephrine. See catecholamine. dopamine One of the catecholamines, widely distributed in the central nervous system. DA1 agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. and appears, based on the results of our studies, to have specific beneficial effects on both the cardiovascular system cardiovascular system: see circulatory system. cardiovascular system System of vessels that convey blood to and from tissues throughout the body, bringing nutrients and oxygen and removing wastes and carbon dioxide. and the kidney. Neurex Corp. is developing products for acute care, principally in the area of cardiorenal and neurological disease. Neurex's products under development, CORLOPAM (fenoldopam) and SNX-111, are currently in advanced stage human trials. An NDA for CORLOPAM was filed in June 1996. Each product has potential in multiple indications. The company's strategy is to discover, develop and commercialize its products for acute care treatment in hospital settings, such as emergency rooms, intensive care units and pain clinics. CONTACT: Neurex Corp. Paul Goddard PhD, 415/833-1288 or Burns-McClellan, Inc. Lisa Burns/John Nugent, 212/505-1919 |
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