NRP104 Meets Primary Endpoint in Phase II Study

New River Pharmaceuticals has provided results from the Phase II trial on its lead drug under development, NRP104.

A total of 52 children aged 6-12 with attention-deficit/hyperactivity disorder (ADHD) were enrolled in a double-blind, placebo- and active-controlled, randomized, three-treatment, three-period crossover study that compared NRP104's and Adderall XR's efficacy, duration and incidence of adverse events to placebo.

The primary efficacy endpoint in this study was SKAMP-Deportment (Swanson, Kotkin, Agler, M.Flynn and Pelham rating scale). In the study, patients treated with NRP104 showed a statistically significant improvement on primary endpoint compared to placebo across all three doses. The company said the studies also demonstrated that efficacy results of NRP104, when compared to placebo, and Adderall XR, when compared to placebo, were similar in terms of primary and secondary endpoints and should support the filing for the inclusion of a dose-conversion table in the label of NRP104.

The significant therapeutic effects of NRP104 continued throughout the last assessment time point (i.e., 12 hours post morning dose), compared to placebo, suggesting a 12-hour duration of drug action. In this study, NRP104 was generally well-tolerated, with adverse events of a nature consistent with those in the approved labeling for Adderall XR and other stimulant therapies.