Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.New River Pharmaceuticals has provided results from the phase II trial on its lead drug under development, NRP104, revealing that the ADHD drug met the study's primary endpoint.
Subscribe to our email newsletter
A total of 52 children with ADHD were enrolled in a crossover study that compared NRP104 and Shire Pharmaceuticals’ Adderall XR to placebo in terms of efficacy, duration and incidence of adverse events.
In the study, patients treated with NRP104 showed a statistically significant improvement on the study’s primary endpoint scale compared to placebo across all three doses administered.
New River believes that 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.
In the study, NRP104 was also generally well tolerated, with adverse events of a nature consistent with those in the approved labeling for Adderall XR and other stimulant therapies.
New River recently reached an agreement to collaborate with Shire on the marketing and commercialization of NRP104.