FRAZER, Pa., Dec. 5 /PRNewswire-FirstCall/ -- Cephalon, Inc. today announced that results of a clinical study evaluating SPARLON(TM) (modafinil) Tablets [C-IV] for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents have been published in this month’s issue of Pediatrics, the peer-reviewed journal of the American Academy of Pediatrics. In the study, SPARLON significantly improved the symptoms associated with ADHD as reported by physicians, parents and teachers, and was generally well tolerated.
“In this study, children and adolescents treated with once-daily SPARLON showed improvement in ADHD symptoms, including inattention, impulsivity, and hyperactivity, both at school and at home,” said Joseph Biederman, M.D., chief, Department of Pediatric Psychopharmacology, Massachusetts General Hospital, professor of Psychiatry at Harvard Medical School, and a lead investigator in the trial. “SPARLON also was associated with a favorable side effect profile.”
About the Study
The published study is one of three pivotal studies of SPARLON for the treatment of ADHD in children and adolescents. The nine-week, double-blind, flexible-dose study included 248 children and adolescents with ADHD (ages six to 17 years) who were randomized to either once-daily SPARLON or placebo. The primary endpoint was the teacher/physician-completed ADHD Rating Scale-IV (ADHD-RS-IV) School Version total score. Symptom improvement also was rated using a variety of other scales, including evaluations by parents.
In the study, patients treated with SPARLON showed significantly greater improvement than with placebo in the core symptoms of ADHD at school and home (both p<0.0001). By the end of the study, 48 percent of patients treated with SPARLON were rated by physicians as “much” or “very much” improved compared with 17 percent of patients who received placebo (p<0.0001).
In the study, SPARLON was generally well tolerated and discontinuation rates due to adverse events were not significantly different from placebo. The most common adverse events associated with SPARLON were generally mild to moderate in nature and included insomnia, headache and decreased appetite.
SPARLON
SPARLON is a new dosage form of modafinil, the active ingredient in PROVIGIL(R) (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. PROVIGIL is not approved to treat ADHD. Cephalon has submitted data to the FDA requesting approval to market SPARLON for the treatment of ADHD in children and adolescents. The FDA has not yet determined that SPARLON is safe and effective. If approved, SPARLON is expected to be available in early 2006.
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain.
Cephalon currently employs approximately 2,500 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon’s European headquarters are located in Maisons-Alfort, France and other European offices are located in Guildford, England, and Martinsried, Germany.
The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] and TRISENOX(R) (arsenic trioxide) injection and more than 20 products internationally. Full prescribing information for all U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, including the results of the SPARLON clinical trials, prospects for final regulatory approval of SPARLON, including the anticipated timetable for the launch of the product, manufacturing development and capabilities, market prospects for its products, particularly with respect to SPARLON sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Cephalon, Inc.
CONTACT: Media, Jenifer Antonacci of Cephalon, +1-610-738-6674,jantonac@cephalon.com, or Kerry Dixon, +1-720-216-0011, orkdixon@gcigroup.com, for Cephalon, or Investors, Robert (Chip) Merritt ofCephalon, +1-610-738-6376, cmerritt@cephalon.com
Web site: http://www.cephalon.com/
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