Pain Medicine

IND filed for testing of extended release Ibuprofen

Published in Medical Letter on the CDC and FDA, January 16th, 2005

SCOLR Pharma, Inc. (AMEX:DDD) announced that the company has submitted an investigational new drug application (IND) with the United States Food and Drug Administration (FDA) to initiate human testing of an extended release Ibuprofen formulation for the over-the-counter (OTC) market.

The OTC 12-hour extended release Ibuprofen formulation is based on SCOLR Pharma's proprietary and patented CDT drug delivery platform. There are currently no extended release formulations of Ibuprofen approved for use in North America.

SCOLR's IND seeks permission from the FDA to begin a U.S. human study intended to support future product approval. The FDA requires a...

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Source: Medical Letter on the CDC and FDA (2005-01-16)

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