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New River Pharmaceuticals Announces Filing of Investigational New Drug Application for NRP409.

Publication: PR Newswire

Publication Date: 30-JUN-06
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COPYRIGHT 2006 PR Newswire Association LLC

RADFORD, Va., June 30 /PRNewswire/ -- New River Pharmaceuticals Inc. announced today that an investigational new drug application (IND) has been submitted to the U.S. Food and Drug Administration for NRP409.

On June 29, New River submitted an IND on NRP409, the company's Carrierwave(TM) 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 3Q06. The company anticipates that NRP409 should warrant a relatively abbreviated development pathway...

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