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Great news, expecially re Entacapone field studies. Bob Cowan <[log in to unmask]> 06/18 0903 STUDY SUGGESTS NEW MEDICATION OVERCOMES OBSTACLE ... VIENNA, Austria, June 18 /PRNewswire/ -- According to results announced at this week's 4th International Congress of Movement Disorders, a new Parkinson's medication called entacapone reduces fluctuations in motor performance that commonly occur in patients being treated with levodopa. The SEESAW (Safety and Efficacy of Entacapone Study Assessing Wearing Off) study found that entacapone managed these fluctuations, while prolonging the effectiveness of levodopa and reducing the need for levodopa increases. The trial was conducted by the Parkinson's Study Group (PSG), a leading consortium of Parkinson's disease (PD) researchers. Entacapone belongs to a new class of drugs under investigation known as catechol-O-methyltransferase or COMT-inhibitors, which have a novel mechanism of action. These agents have been shown to be safe and effective with other adjunctive PD medications and to prolong the duration of action of levodopa, thus avoiding problems related to levodopa's "wearing off" phenomenon. Traditionally the mainstay of PD treatment, chronic levodopa use leads to motor fluctuations and involuntary movements. "Of particular importance, these patients were able to continue all other anti-Parkinsonian medications including dopamine agonists and selegiline," said Karl Kieburtz, MD, MPH, Associate Professor of Neurology, University of Rochester, New York, USA. "The introduction of entacapone therefore provided a significant additional benefit even in the presence of conventional therapies." The study included 205 optimally-treated patients with levodopa- related motor fluctuations at 18 centers in the US and Canada. The participants were randomized to receive either entacapone (200 mg daily) or placebo with each dose of carbidopa/levodopa and were followed for 28 weeks. At 24 weeks, Unified Parkinson's Disease Rating Scale (UPDRS) scores had worsened by three points in the placebo group, who were taking 20.7 mg more levodopa. UPDRS scores improved by one point in the entacapone treatment group, who required 101.9 mg less levodopa. Entacapone also increased "on" or good time significantly (p 0.005). UPDRS is a standard international tool to measure functional ability. "This is significant as Parkinson's disease is a chronic disorder and patients progressively decline over time," added Dr. Kieburtz. "A significant improvement in motor scores, as shown in the SEESAW trial, is therefore very positive." Several other presentations at the meeting provided evidence of entacapone's therapeutic potential. Among them, Scandinavian researchers from 16 clinical sites, led by Urpo K. Rinne, MD, PhD, Professor of Neurology, University of Turku, Finland, found that "on" time based on home diaries increased significantly in entacapone- compared with placebo-treated patients. The results persisted throughout the six-month study. The trial included 171 patients who had developed motor fluctuations during optimal levodopa treatment. Entacapone was generally well tolerated, although there was a slight increase in gastrointestinal side effects including nausea and abdominal pain. Parkinson's disease is a chronic, progressive neurological disorder that affects motor function. Primary symptoms include muscle rigidity, tremor, a decrease in the range and frequency of voluntary movements, and abnormalities in posture and gait. The studies were sponsored by Orion Pharma of Finland. Entacapone will be co-marketed internationally by Sandoz Pharma Ltd. -0- 6/18/96 /CONTACT: John Quick of Ogilvy Adams & Rinehart, 212-880-5259/ CO: Sandoz Pharma Ltd. ST: IN: MTC SU: Copyright 1996 06/18 0853 Discovery Therapeutics' Parkinson's Treatment ... VIENNA, AUSTRIA (June 18) BUSINESS WIRE -June 18, 1996--Discovery Therapeutics, Inc., a privately-held pharmaceutical company located in Richmond, Va., today announced the presentation of the first human data for its N-0923 transdermal patch product for the treatment of Parkinson's Disease. Dr. Vincent P. Calabrese, M.D., Associate Professor of Neurology, Medical College of Virginia, will present the data in poster sessions June 19- 21, 1996 at the Fourth International Congress of Movement Disorders in Vienna. The data are from Discovery's recent human pharmacokinetic and safety study of N-0923, a potent dopamine replacement molecule specifically designed and optimized for delivery through the skin. More than $1 billion dollars (U.S.) are spent worldwide for therapeutic agents to treat Parkinson's Disease, a debilitating neurological disorder that afflicts more than 1% of the U.S. and European population over the age of 50. Patients experience rigidity, difficulty in walking, muscle tremor and slowness of movement. The disease is caused by degeneration of the portion of the brain that secretes dopamine, a neurotransmitter signal molecule used to coordinate voluntary muscle activity. "I think this drug is going to become an important treatment for Parkinson's Disease," said Dr. Calabrese. "This study demonstrates that transdermal delivery can maintain consistent levels of drug in the blood without the ups and downs associated with oral delivery. Delivery through the skin avoids the side effects of oral delivery for any patient, and provides the first practical alternative in the United States for the patient who cannot take medication by mouth. "The N-0923 molecule itself is structurally different from available therapies. In addition to being optimized for transdermal delivery, it is a very specific non-ergot-based dopamine agonist that avoids side effects, such as dyskinesia (jerky movements) and the gastrointestinal distress associated with less specific and ergot-based compounds." The company has just completed a study of the efficacy of the N-0923 patch in Parkinson's Disease patients. Preliminary results are encouraging and the data will be submitted this summer for publication, probably to appear early next year. The company plans to proceed with Phase III within the next few months and will seek a marketing partner. Discovery Therapeutics, Inc. is an independent company founded to invent, develop and commercialize pharmaceuticals for poorly-met medical needs using novel signal molecule technology. In addition to its transdermal product for treating Parkinson's Disease, Discovery Therapeutics Inc. is developing new products for improved diagnosis and treatment of coronary artery disease. These include an agent designed to selectively dilate coronary blood vessels to facilitate cardiac imaging diagnostic procedures. Use of this agent should result in fewer side effects and improved imaging than is possible with the current generation of vasodilating imaging agents. The company intends to begin clinical trials with this product in 1996. Another product is in human trials for the treatment of cardiac rhythm disorders. --30--lmm/sf dc/sf CONTACT: Discovery Therapeutics Dr. Donald A. McAfee, 804/358-9468 or EMM Communications Ellen M. Martin, 510/832-7604 KEYWORD: VIRGINIA INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL BIOTECHNOLOGY REPEATS: New York 212-752-9600 or 800-221-2462; Boston 617-236-4266 or 800-225-2030; SF 415-986-4422 or 800-227-0845; LA 310-820-9473 BW URL: http://www.businesswire.com Copyright 1996