To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Dostinex to Treat Hyperprolactinemia Receives FDA Clearance URL: http://www.pslgroup.com/dg/F666.htm Doctor's Guide December 26, 1996
KALAMAZOO, Mich., Dec. 26, 1996 -- Pharmacia & Upjohn announced today that the U.S. Food and Drug Administration has granted marketing clearance for the prescription sale of Dostinex Tablets (cabergoline tablets) for treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas (tumors). Dostinex will be available in March 1997. Dostinex is a major advance for patients with this disorder, said William E. Walker, director of women's health marketing for P&U's North American Market Region. It is effective, generally well-tolerated, and with twice-a-week dosing, convenient to take. We are pleased to offer this new treatment option to physicians and patients." Hyperprolactinemia is usually caused by a benign tumor on the pituitary gland that results in excess production of prolactin, the hormone that controls lactation. Doctors treat from 70,000 to 100,000 patients with the condition each year, the vast majority of whom are women. It most commonly affects women ages 20-50 and can cause cessation of menstruation, excessive breast milk discharge and infertility. In men the condition can cause decreased libido and impotence. Dostinex joins bromocriptine as the only other drug product indicated to treat hyperprolactinemia, however, Dostinex is more convenient for patients (two doses per week for Dostinex versus one to three doses each day for bromocriptine). "Dostinex is an effective and generally well-tolerated treatment for patients with hyperprolactinemia," said Anne Klibanski, M.D., chief of the neuroendocrine unit, Massachusetts General Hospital in Boston. "Patient compliance is high, due to the side effect profile and convenient twice-a-week dosing. Given the efficacy and safety profile demonstrated in clinical trials, I believe Dostinex will become a valuable treatment choice." In a clinical trial involving approximately 450 patients, Dostinex was compared with bromocriptine in treating hyperprolactinemia. In the eight- week, double-blind trial, prolactin levels returned to normal in 77% of patients treated with Dostinex (0.5 mg twice-weekly) compared to 59% of those treated with bromocriptine (2.5 mg twice-daily). Restoration of menses occurred in 77% of women treated with Dostinex, compared to 70% of those treated with bromocriptine. Among patients with galactorrhea (excessive breast milk discharge), the symptom disappeared in 73% of those treated with Dostinex, compared to 56% of those treated with bromocriptine. Clinical studies also showed the safety profile of Dostinex compares favorably to bromocriptine. Two percent of 221 patients taking Dostinex discontinued treatment due to side effects during the eight-week study, versus six percent of 231 patients taking bromocriptine. Nausea is the most common side effect of both drugs. During the eight- week, double-blinded portion of the trial, 29% of patients experienced nausea with Dostinex compared with 43% of those taking bromocriptine. Dostinex is contraindicated in patients with uncontrolled hypertension or known hypersensitivity to ergot derivatives. Pharmacia & Upjohn, Inc. (NYSE: PNU), is a research-based pharmaceutically focused company dedicated to helping people around the world live longer and fuller lives. The company was formed through a merger of Pharmacia AB and The Upjohn Company and began operating in November 1995. Pharmacia & Upjohn, Inc. is a provider of human health care and related products and operates on a global basis. The company has a corporate management center in London and major research and manufacturing centers in the United States, Sweden and Italy. --------------------------------------------------------------------------------------------- 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.