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.
Company officials conducted a meeting in early May with clinical investigators participating in the study. “It was an upbeat and a positive meeting,” remarked Suma Krishnan, New River’s vice president of product development. “We are pleased to begin screening on the clinical investigation of NRP104 as a potential treatment to address adult ADHD.”
NRP104 is the subject of a collaborative development and commercialization agreement between New River and Shire.
In December 2005, New River submitted to the FDA a new drug application seeking approval to manufacture and market NRP104 for the treatment of ADHD in pediatric populations (ages six to 12). The date by which the FDA is expected to review and act on this submission is October 6, 2006. New River and Shire hope to launch NRP104 as a treatment for pediatric ADHD by January 2007.
It is estimates that 8.5 million adults in the US suffer from ADHD, and that 75% of these people remain undiagnosed, under-treated or untreated.