Biovail Initiates Tramadol Phase III Clinical Trials.Business Editors & Health/Medical Writers TORONTO--(BW HealthWire)--Sept. 19, 2000 Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency ) (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF) today announced that they have entered Phase III clinical trials for a once-daily version of Tramadol. Tramadol is currently marketed in the United States by a division of Johnson and Johnson and is only available in an immediate-release, three to four times per day dosage format. Sales for the existing immediate-release version of Tramadol for the twelve months ended July 2000 were in excess of $475 million. Tramadol is indicated for the treatment of a variety of chronic pain syndromes with associated moderate to moderately severe pain. Pain is a common symptom of many diseases and is generally seen in everyday clinical practice. Biovail is initiating two double-blind efficacy studies for moderate to moderately severe pain. Patient dosing for these studies is 12 weeks in duration and the Company expects the studies to be completed in approximately one year. Biovail also stated that it is in late stage development of additional novel once-daily controlled-release formulations in the anxiety disorders Anxiety disorders A group of distinct psychiatric disorders characterized by marked emotional distress and social impairment, including generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. therapeutic class. Biovail anticipates the initiation of additional Phase III clinical trials for once-daily formulations that are currently only available in multi-dose formats over the coming months. Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the successful outcome of Phase III clinical trials, difficulty of predicting FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. |
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