Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

New River NRP104 Phase III data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

New River's d-amphetamine prodrug NRP104 showed statistically significant results for primary and secondary endpoints in a Phase III study of children with attention deficit hyperactivity disorder, the firm reports May 23. The study of 285 patients aged six to 12 showed that each of three doses of NRP104 had a significant outcome for the ADHD Rating Scale (primary) and the Conners Parent Rating Scale (p<0.0001), New River said. New River is collaborating with Shire on NRP104; the firms signed a global commercialization deal in January. NRP104 is expected to reach the market by 2006 (1Pharmaceutical Approvals Monthly February 2005, p. 19)...

You may also be interested in...



Shire/New River NRP104 submission

Shire and New River are seeking a pediatric indication for children ages six to 12 for the attention deficit/hyperactivity disorder therapy NRP104. New River submitted an NDA for the amphetamine prodrug Dec. 6, giving FDA an Oct. 6, 2006 standard review action date. Lower abuse liability is one of the key advantages the sponsors hope to claim vis-à-vis currently marketed stimulant ADHD agents. The firms reported positive Phase III data for the new molecular entity in May (Pharmaceutical Approvals Monthly June 2005, In Brief)...

Licensing In Brief

Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

Topics

UsernamePublicRestriction

Register

OM006665

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel