New River files IND for thyroid hormone-replacement therapy

By Elaine Rigoli

Tampa, Fla., June 30 - New River Pharmaceuticals, Inc. said Friday that it has filed an Investigational New Drug application with the Food and Drug Administration for NRP409, the company's Carrierwave triiodothyronine (T3) hormone, as a treatment for patients with primary hypothyroidism.

The company said it 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 about half a century.

New River expects to begin enrollment in clinical studies of NRP409 in the third quarter of 2006.

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 plc.

NRP104 is under review by the FDA as a potential treatment for pediatric attention deficit/hyperactivity disorder. Should New River decide to exercise this option, it expects to field about 100 sales representatives in the first half of 2007.

New River is a specialty pharmaceutical company located in Radford, Va.

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