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.