www.fdanews.com/articles/87019-new-river-initiates-pivotal-trial-of-nrp104
NEW RIVER INITIATES PIVOTAL TRIAL OF NRP104
May 23, 2006
New River Pharmaceuticals has reported that screening has begun in a pivotal Phase III clinical trial for NRP104 for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adult populations (ages 18 to 55). The outcome of this trial is anticipated to support a supplemental new drug application (sNDA), which the company hopes to file with the FDA in the second quarter of 2007.
NRP104 is the subject of a collaborative development and commercialization agreement between New River and Shire.