New River files NRP409 IND

New River Pharmaceuticals says that an investigational new drug application has been submitted to the US Food and Drug Administration for NRP409, its Carrierwave tri-iodothyronine (T3) hormone, as a treatment for patients with primary hypothyroidism. The company hopes that, by reducing the variation 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 the third quarter and anticipates that the product should warrant a relatively abbreviated development pathway and hopes to file a New Drug Application by the end of 2007.

While the US market for thyroid hormone replacement therapy is significant, with roughly three billion doses per year, the field of endocrinology is concentrated enough that the company expects to be able to commercialize and market NRP409 without a partner.