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 submitted an investigational new drug application to the FDA for its hypothyroidism treatment candidate NRP409.
Subscribe to our email newsletter
New River has filed the investigational new drug (IND) application for NRP409, a triiodothyronine (T3) hormone, as a treatment for patients with primary hypothyroidism.
The company hopes that by reducing the variability of the hormone’s availability, while reducing the safety risk associated with other T3-based therapies, NRP409 will mark the first significant improvement in thyroid hormone replacement therapy in approximately half a century.
New River expects to begin enrollment in clinical studies of NRP409 by Q3 2006 and hopes to file a new drug application (NDA) by the end of 2007.
New River also announced that it is evaluating whether to exercise its option to co-promote NRP104 in accordance with a collaboration agreement with Shire. NRP104 is currently under review with the FDA as a potential treatment for pediatric ADHD.