RADFORD, Va., May 24 /PRNewswire-FirstCall/ -- New River Pharmaceuticals Inc. (New River) announced today that treatment with the investigational drug NRP104 demonstrated statistically significant reduction in the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 years according to the results of a phase III trial presented today at the American Psychiatric Association (APA) annual meeting.
In the study, 30-milligram (mg), 50 mg, and 70 mg QD doses of lisdexamfetamine dimesylate (NRP104) demonstrated significant improvements in ADHD symptoms compared with placebo (P<0.0001) after four weeks of once-daily treatment, as measured by 230 children’s scores on the ADHD Rating Scale (ADHD-RS). ADHD-RS is a standard test for diagnosing ADHD in children and adolescents and for assessing their response to treatment.
Average reductions in ADHD-RS scores were 50 percent (21.8 points), 54 percent (23.4 points) and 59 percent (26.7 points) for the 30 mg, 50 mg, and 70 mg dosage strengths, respectively, compared to baseline. All three NRP104 doses produced significant decreases in the scores during the first week of treatment (P<0.0001 versus placebo for each dose). Of the participants, 36 percent had previously received treatment for ADHD.
Each of the three dosage strengths (30 mg, 50 mg and 70 mg per day) demonstrated efficacy in the morning (~10:00 am); afternoon (~2:00 pm); and into evening (~6:00 pm), compared to placebo, as demonstrated by the Conners’ ADHD Rating Scale - Parent (CPRS).
Most adverse events were mild to moderate and occurred in the first week. The most common adverse events were decreased appetite, insomnia, headache and upper abdominal pain. No unexpected adverse events in incidence or severity were observed in this study.
The four-week pivotal phase III trial was designed to replicate the actual therapeutic setting. In addition to the results on efficacy, tolerability and duration of action, of particular interest were the data on QT interval:
QT Interval Placebo 30mg 50mg 70mg (msec) Baseline Mean (SD) 351 (23.3) 348 (21.8) 348 (24.9) 345 (21.2) Endpoint Mean (SD) 352 (24.5) 347 (21.2) 344 (22.0) 343 (17.9) Change (SE) 2.3 (2.01) -1.3 (2.03) -3.2 (2.00) -3.4 (1.99)
No clinically significant differences in QT interval were observed in change from baseline to endpoint for any of the dosage strengths in this trial.
NRP104 is the subject of a collaborative development and commercialization agreement between New River and Shire plc .
About New River
New River Pharmaceuticals Inc. is a specialty pharmaceutical company developing novel pharmaceuticals that are generational improvements of widely prescribed drugs in large and growing markets.
For further information on New River, please visit the company’s website at http://www.nrpharma.com.
“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995. Forward- looking statements are statements that are not historical facts. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, financial projections and estimates and their underlying assumptions; statements regarding plans, objectives and expectations with respect to future operations, products and services; and statements regarding future performance. Such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of New River Pharmaceuticals, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include: those discussed and identified in the New River Pharmaceuticals Inc. annual report on Form 10-K, filed with the SEC on March 15, 2006; the timing, progress and likelihood of success of our product research and development programs; the timing and status of our preclinical and clinical development of potential drugs; the likelihood of success of our drug products in clinical trials and the regulatory approval process; our drug products’ efficacy, abuse and tamper resistance, onset and duration of drug action, ability to provide protection from overdose, ability to improve patients’ symptoms, incidence of adverse events, ability to reduce opioid tolerance, ability to reduce therapeutic variability, and ability to reduce the risks associated with certain therapies; the ability to develop, manufacture, launch and market our drug products; our projections for future revenues, profitability and ability to achieve certain sales targets; our estimates regarding our capital requirements and our needs for additional financing; the likelihood of obtaining favorable scheduling and labeling of our drug products; the likelihood of regulatory approval under the Federal Food, Drug, and Cosmetic Act without having to conduct long and costly trials to generate all of the data which are often required in connection with a traditional new chemical entity; our ability to develop safer and improved versions of widely prescribed drugs using our Carrierwave (TM) technology; and our ability to obtain favorable patent claims. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. New River Pharmaceuticals does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in New River Pharmaceuticals’ annual report on Form 10-K, filed with the SEC on March 15, 2006, as well as other public filings with the SEC.
Contacts: The Ruth Group John Quirk (investors) 646-536-7029 jquirk@theruthgroup.com Zack Kubow (media) 646-536-7020 zkubow@theruthgroup.com
New River Pharmaceuticals Inc.
CONTACT: John Quirk - investors, +1-646-536-7029, jquirk@theruthgroup.com,or Zack Kubow - media, +1-646-536-7020, zkubow@theruthgroup.com
Web site: http://www.nrpharma.com/
