To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ENDO: Buccal Tablet Provides More Convenient Testosterone Dosing URL: http://www.pslgroup.com/dg/216966.htm Doctor's Guide June 24, 2002
By Paula Moyer Special to DG News SAN FRANCISCO, CA -- June 24, 2002 -- A testosterone tablet that adheres to the buccal mucosa and becomes a gel is a convenient way to deliver testosterone effectively and discreetly. Investigators presented these findings on the buccal adhesive tablet here June 20th at ENDO 2002, the 84th annual meeting of the Endocrine Society. Testosterone must be delivered by non-enteral means. As a result, administering the hormone to hypogonadal men has been a logistical challenge. Current delivery systems include injections, skin patches, and gels, which pose problems that include skin irritation and risk of transferring testosterone to others through physical contact. The investigators of a testosterone bioadhesive buccal tablet evaluated it in an open-label trial for its ability to provide androgen replacement therapy in hypogonadal men. The patient applies the adhesive tablet, 8 mm in diameter, to the anterior upper gum twice daily. As it hydrates, the tablet becomes a gel, and a stable level of testosterone is released and absorbed across the buccal mucosa through the 12-hour dosing period. In this study, nine centres recruited 98 hypogonadal men, who ranged in age from 20 to 75 years old. The patients participated in a three-month trial of replacement therapy with the testosterone buccal tablet. They applied the tablet twice daily to the upper gums for the trial period. During the last day of therapy, investigators measured the men's serum testosterone multiple times over a 24-hour period. They drew blood through a canula inserted into the patient's vein. Over the course of the trial, the investigative team also measured the men's dihydrotestosterone. The data obtained during the 24-hour sampling were used for the analysis of the testosterone pharmacokinetic parameters. Of the 98 original participants, 84 completed the trial and provided data for analysis. These subjects' mean testosterone concentration over the 24-hour observation period was 5.3 ng/mL (SD 2.4 ng/mL). Among these patients, 71 (85 percent) had an average testosterone concentration over the 24-hour period within the physiologic range of 3 to 10.5 ng/mL. The serum testosterone concentration was within the physiologic range during the 24-hour a mean 79.6 percent of the observation time. Testosterone-dihydrotestosterone ratios remained physiologic and unchanged throughout the testing period. At baseline, the mean ratio was 9.49 (SD 4.43); at the study's end, the mean ratio was 9.21 (SD 3.49)]. Oestradiol serum concentrations rose from 16.7 pg/ml at baseline to 34.4 pg/ml at the end of the study. Local problems associated with the tablet were primarily irritation and pain and typically resolved within seven days of the study's onset. Among the 84 patients who completed the study, 47 (55.4 percent) stated that the tablet was as good or better than their previous form of testosterone replacement, the investigators stated. "Among the men in this study, 60 percent said they wanted to continue to use the tablet at the study's end," said Howard Levine, PharmD, a representative of Columbia Research Laboratories, Inc., the manufacturers of the buccal tablet. "The tablet seems to have good local tolerance after the first few days, and does not interfere with eating, drinking, or talking." --------------------------------------------------------------------------------------------- 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.