Noven Announces Scheduled Presentation of Phase III Data for Once-Daily ADHD Patch; Pivotal Trial Data to be Presented October 24th at AACAP Annual Meeting.Business Editors/Health & Medical Writers MIAMI--(BUSINESS WIRE)--Oct. 10, 2002 Noven Pharmaceuticals, Inc. (Nasdaq:NOVN) today announced that Phase III and other clinical study data for its once-daily methylphenidate methylphenidate /meth·yl·phen·i·date/ (meth?il-fen´i-dat) a central stimulant, used in the form of the hydrochloride salt in the treatment of attention-deficit in children and narcolepsy. transdermal system will be presented at the 49th Annual Meeting of the American Academy of Child and Adolescent Psychiatry A branch of psychiatry that specialises in work with children, teenagers, and their families. History An important antecedent to the specialty of child psychiatry was the social recognition of childhood as a special phase of life with its own developmental stages, starting with (AACAP AACAP American Academy of Child and Adolescent Psychiatry AACAP ATSIC/Army Community Assistance Program AACAP Area Agency on Aging of the Capital Area (Texas) ) in San Francisco. The principal presentation, entitled "Once-Daily Transdermal Methylphenidate Improves Teacher, Parent and CGI-I CGI-I Clinical Global Impression Improvement (psychological scale) Ratings", is scheduled to take place on the afternoon of October 24, 2002. The presentation will offer insight into Noven's successful double-blind, placebo-controlled, multi-center Phase III study, completed in March 2002, that involved over 200 patients between the ages of 6 and 12. The study was conducted to assess the efficacy and safety of Noven's developmental methylphenidate patch for Attention-Deficit Hyperactivity Disorder Attention-deficit hyperactivity disorder (ADHD) A condition in which a person (usually a child) has an unusually high activity level and a short attention span. People with the disorder may act impulsively and may have learning and behavioral problems. (ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or ), which Noven intends to market under the trade name MethyPatch(R). The study was part of a MethyPatch clinical trial program sponsored by Noven that spanned several years and included over 700 subjects in centers across the U.S. MethyPatch combines methylphenidate -- an established ADHD therapy -- with Noven's patented DOT Matrix(TM) patch technology. DOT Matrix permits Noven to deliver predictable therapeutic doses of a range of prescription therapies through discreet, comfortable and adherent adherent /ad·her·ent/ (-ent) sticking or holding fast, or having such qualities. patches that are well suited to active lifestyles. In June 2002, Noven submitted a New Drug Application to the U.S. Food & Drug Administration seeking approval to market MethyPatch for the treatment of ADHD, and the application is currently under review. ADHD is characterized by developmentally inappropriate impulsivity, inattention in·at·ten·tion n. Lack of attention, notice, or regard. Noun 1. inattention - lack of attention basic cognitive process - cognitive processes involved in obtaining and storing knowledge and hyperactivity. ADHD affects 3% to 5% of school-aged children, and an estimated 1.5 million children are currently on medication to treat this disorder. All presently approved ADHD medications are delivered orally. AACAP is a medical membership association established by child and adolescent psychiatrists in 1954. With over 6,500 members, AACAP is the leading national medical association dedicated to treating and improving the quality of life for the estimated 7-12 million American youth under 18 years of age who are affected by emotional, behavioral, developmental and mental disorders. For additional information on the AACAP Annual Meeting, see http://www.aacap.org. Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Together with Novartis Pharmaceuticals Corporation, Noven owns a highly profitable women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. products company called Novogyne Pharmaceuticals. Noven's existing products include advanced estrogen and combination estrogen/progestin transdermal delivery systems transdermal delivery system: see skin patch. using DOT Matrix technology. With a range of additional products in development, including MethyPatch, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal drug delivery systems. For additional information, visit Noven's website at http://www.noven.com. MethyPatch(R) and DOT Matrix(TM) are trademarks of Noven Pharmaceuticals, Inc. This release contains forward-looking statements related to the business of Noven that can be identified by the use of forward-looking terminology such as "expects" and similar words and phrases Words and Phrases® A multivolume set of law books published by West Group containing thousands of judicial definitions of words and phrases, arranged alphabetically, from 1658 to the present. . Such statements are qualified by and subject to the risks and uncertainties specified in Noven's most recent filings with the Securities and Exchange Commission and in this press release, including the risk that MethyPatch may not be approved or, if approved, that it may not be the first transdermal ADHD therapy on the market or that it may not be successfully commercialized due to competitive market conditions or other factors, including physician/patient preferences for other ADHD therapies. 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. will examine data from the most recent Phase III study together with data from other MethyPatch studies sponsored by Noven, and there can be no assurance that FDA will deem all of such data sufficient to approve the product for marketing or to authorize the product's use in the manner described by Noven. The timing of any FDA approval is outside the control of Noven. There are several other once-daily ADHD medications on the market, and other products that may have improved safety and efficacy profiles are also in development. |
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