To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Cool.click Needle Free Device For Saizen (Somatropin) Growth Hormone URL: http://www.pslgroup.com/dg/1D77C6.htm Doctor's Guide June 26, 2000
PORTLAND, OR -- June 26, 2000 -- Bioject Medical Technologies Inc. , a leading developer of needle-free drug delivery systems announced today that the US Food and Drug Administration (FDA) has granted marketing clearance for a needle-free device to deliver Serono's Saizen® recombinant pediatric growth hormone. Bioject will be the first company to provide a needle-free delivery system for growth hormone in the United States. The needle-free delivery device, called Cool.click™, allows physicians and nurses to offer an alternative to patients over traditional needles and syringes. Cool.click will be launched by Serono later this summer in the U.S. for use with Saizen [somatropin (rDNA origin) for injection]. Cool.click was developed for the delivery of Saizen in partnership with Serono through an exclusive license agreement announced in January 2000. The device has been customized and tested for use with Saizen's product specifications, and will be sold under the Serono brand. "Based on our clinical studies, the Cool.click needle-free delivery device reduces the fear and anxiety that many parents and patients experience with needle injections," said Janet Silverstein, MD, Director of Pediatric Endocrinology at University of Florida Shands Medical Center. "It provides a simple, easy-to-use solution with less pain and anxiety." "Patients and parents are often apprehensive about treatment with daily needle injections," said Sara Myers, a Pediatric Endocrinology nurse at the University of South Florida, All Children's Hospital in St. Petersburg, Fl. "Now, for the first time ever, Cool.click needle-free growth hormone delivery offers a choice to patients who don't like or are fearful of needles." With Cool.click, Saizen is dispersed through the skin in a fine mist in less than a second. The drug is delivered subcutaneously, distributed by the bloodstream, and is bioequivalent to needle injections. In addition to offering patients an alternative to conventional needles, the Cool.click needle-free growth hormone delivery device eliminates the biohazard associated with disposal of conventional used needles. As with needle injection, some injection site reactions may be experienced with the needle-free delivery device. Cool.click is designed with easy-to-read measurements to provide dose accuracy. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.