To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Clears Long-Acting Lupron Injections For Advanced Prostate Cancer URL: http://www.pslgroup.com/dg/30D2A.htm Doctor's Guide July 21, 1997
DEERFIELD, ILL. -- July 21, 1997 -- TAP Holdings Inc. (TAP) announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Lupron Depot(R)-4 Month 30 mg (leuprolide acetate for depot suspension) for palliative treatment of advanced prostate cancer. Because of the drug's long-acting formulation, patients receive only one injection of Lupron Depot-4 Month 30 mg every 16 weeks to treat their condition. Prostate cancer is now the second leading cause of cancer deaths in men. In 1997, the American Cancer Society estimated that 334,500 men were newly diagnosed with prostate cancer and that approximately 41,800 will die from the disease in 1997. "This is a significant benefit for men with advanced-state prostate cancer," said Roohollah Sharifi, M.D., Professor of Surgery and Urology, University of Illinois at Chicago Medical Center. "Men will be able to visit their physician's office every 16 weeks for an injection. It's convenient for the patients." Lupron Depot is a member of a class of drugs known as gonadotropin releasing hormone (GnRH) analogs. Lupron Depot-4 Month 30 mg works by inhibiting the production of the hormone testosterone, which may play a significant role in the growth of prostate cancer. Decreasing the levels of testosterone in the body may also alleviate bone pain and some urinary problems that may be associated with metastatic prostate cancer. In clinical trials, the safety and efficacy of Lupron Depot-4 Month 30 mg were similar to the other Lupron Depot formulations. The most common side effect reported with Lupron Depot-4 Month 30 mg was hot flashes. Serum testosterone levels may increase approximately 50 percent above baseline during the first week of treatment. Like other treatment options, it may also cause impotence. Symptoms may worsen over the first few weeks of treatment. Lupron Depot is contraindicated in patients who exhibit hypersensitivity to GnRH, GnRH agonist analogs or any excipients in the product. This formulation is not indicated for use in women. For many patients, Lupron offers an alternative to surgical castration (orchiectomy). "Surgical castration is simply not an option many men want," Dr. Sharifi said. "Lupron Depot-4 Month 30 mg offers prostate cancer patients a convenient, effective treatment without the negative psychological effects of surgical castration." TAP Holdings Inc., originally established as TAP Pharmaceuticals Inc. in 1977, is a joint venture of Abbott Laboratories, headquartered in Abbott Park, Illinois, and Takeda Chemical Industries, Ltd. of Osaka, Japan. More information on: TAP Holdings Inc., Abbott Laboratories, Takeda Chemical Industries --------------------------------------------------------------------------------------------- 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.