New River begins pivotal phase 3 trial of NRP104 for treatment of ADHD in adults

By Lisa Kerner

Erie, Pa., May 23 - Screening began in New River Pharmaceuticals Inc.'s pivotal phase 3 clinical trial for NRP104 for the treatment of attention deficit hyperactivity disorder (ADHD) in adults aged 18 to 55.

The outcome of this trial is expected to support New River's supplemental new drug application it hopes to file with the Food and Drug Administration in the second quarter of 2007, according to a news release.

An estimated 8.5 million U.S. adults suffer from ADHD, with 75% of these people undiagnosed, under-treated or untreated.

New River previously filed a new drug application with the FDA for the use of NRP104 in the treatment of ADHD in the pediatric population (ages 6 to 12). The FDA is expected to act on the submission in October.

New River and Shire plc formed a collaborative development and commercialization agreement for NRP104.

New River is a specialty pharmaceutical company based in Radford, Va.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.