To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Phase III trial confirms advantages of levalbuterol over racemic albuterol URL: http://www.pslgroup.com/dg/21666.htm Doctor's Guide March 18, 1997
MARLBOROUGH, Mass.--March 17, 1997-- Sepracor Inc. (Nasdaq: SEPR) today announced that it has completed its pivotal, 362-patient, Phase III bronchodilation study. The findings confirmed the company's Phase II results, which demonstrated an improved therapeutic index of levalbuterol as compared with racemic albuterol. Sepracor has now shown, in a much larger trial, that levalbuterol provides a greater improvement in lung function than racemic albuterol, as measured by FEV1. In addition, at doses showing equivalent efficacy to the marketed racemic albuterol product, levalbuterol demonstrated significantly reduced beta-mediated side effects, such as pulse rate increase. The company expects to file an NDA for levalbuterol by June 30, 1997. Levalbuterol is the purified, active-isomer form of the leading bronchodilator racemic albuterol, sold as Ventolin(r) and Proventil(r). "This pivotal study, which was completed on schedule and is the basis of our upcoming NDA filing, demonstrates levalbuterol's potential to be the bronchodilator of choice based on significant safety and efficacy benefits," stated David S. Barlow, President, Pharmaceuticals. "We look forward to providing this superior therapy to the asthma community in a complete family of dosage forms, beginning with inhalation solution," he added. Sepracor's pivotal bronchodilation trial, involving 362 asthmatic patients at 32 sites, was designed as a parallel-group placebo- controlled study. It compared two doses of levalbuterol with two doses of racemic albuterol inhalation solution given by nebulization, using standard measurements of efficacy and side effects over a four-week period in which patients were dosed three times a day. Lung function was measured at set intervals over an eight-hour period following the initial dose, and periodically throughout the study. The trial confirmed preclinical and Phase II findings that levalbuterol provides a greater improvement in lung function than racemic albuterol. These results were consistent after both single and chronic dosing. In addition, at doses showing equivalent efficacy to the marketed racemic albuterol product, levalbuterol demonstrated significantly reduced beta-mediated side effects. Beta-mediated side effects include pulse rate increase, tremor and decreases in blood glucose and potassium levels. This improvement in therapeutic index was not achieved with either standard or low doses of racemic albuterol. The company plans to submit the results of this trial to a medical journal for publication. Furthermore, unlike previously reported studies demonstrating decreases in pre-dose lung function after chronic exposure to racemic albuterol, treatment with levalbuterol resulted in a significant improvement in pre-dose lung function compared to study baseline. These improvements were not observed in the racemic albuterol treated patients who showed pre-dose FEV1 measurements after four weeks of therapy that were below those of placebo. "The results of this study, particularly with respect to efficacy, are indeed relevant to asthma patients," said Dr. Paul D. Rubin, Senior Vice President, Drug Development. "The lack of deterioration in lung function in patients receiving levalbuterol suggests that the (S)-isomer, known to have no beneficial effect, may actually have played a role in previously observed decreases in lung function. It is also significant to note that lowering the dose of racemic albuterol failed to provide optimal therapeutic response," continued Rubin. --------------------------------------------------------------------------------------------- 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.