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SCOLR Pharma, Inc.
SCOLR Pharma, Inc. Announces Positive Progress for Lead Product
May 18th, 2008
SCOLR Pharma, Inc. (AMEX: DDD) announced that it has received a special protocol assessment from the Food and Drug Administration (FDA) to guide the design of its Phase III pivotal dental pain study to support a New Drug Application (NDA) for an over-the-counter (OTC) 12-hour extended-release (ER) ibuprofen product. SCOLR plans to initiate the study in the next 60 days. In addition, the Company announced it has received positive results from the first of two bioequivalence trials and positive stability results for ER ibuprofen, providing further data to support the application to the FDA. The primary objective of the dental pain study is to evaluate the...
Source: Medical Letter on the CDC & FDA (2008-05-18)
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