Wednesday April 30, 3:19 pm ET

BELLEVUE, Wash.–(BUSINESS WIRE)–SCOLR Pharma, Inc. (AMEX: DDD - News) today 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 efficacy and safety of multiple doses of ER ibuprofen following extraction of third molar teeth. The study is a single-center, randomized, placebo-controlled, double-blind, and parallel group assessment. The study is expected to be completed in late 2008.

SCOLR received a positive final study report from its independent contract research organization for the first of two recently completed bioavailability studies. The report documents the results of ER ibuprofen tablets evaluated in a three-way crossover fed/fasted relative bioavailability study with 35 healthy subjects. The primary objective of the study was to determine the relative bioavailability of SCOLR’s ER ibuprofen 600 milligram (mg) tablets under fed and fasted conditions compared to three tablets of the reference product, Motrin® IB 200 immediate-release tablets, taken over 12 hours. This was a single-center, randomized, open-label, three-period, three-treatment crossover relative bioavailability study. The summary section of the report indicates that the test product, ibuprofen 600 mg extended-release tablets, is “relatively bioavailable to the reference product,” and “that the test and reference products may be interchangeable in clinical usage.”

In addition, SCOLR has completed two-year developmental stability testing on its 600 mg ibuprofen tablets. The data clearly demonstrate that the tablet formulation is stable under room temperature conditions (25º C/60% Relative Humidity) for over two years. There was no change in the tablet’s 12-hour dissolution performance, chemical purity or physical tablet characteristics. Also, SCOLR has completed three months of formal stability testing under room temperature and accelerated storage conditions (40º C/75% Relative Humidity) intended to support its planned NDA. Results to date, exhibit similar trends to the developmental stability. SCOLR will need to complete a minimum of 6 months successful accelerated stability testing before submission of its NDA.

SCOLR has engaged Catalent Pharma Solutions, LLC, a major contract manufacturing organization, to produce the scale-up and registration batches and clinical supplies of ibuprofen, and to conduct stability testing. The data from the manufacturing batches and both the accelerated and room temperature stability testing at Catalent will be used together with the results of the dental pain study and the completed bioavailability studies in support of the NDA.

Ibuprofen is an analgesic typically used for the treatment of pain, fever and inflammation. Total global OTC sales of the analgesic market in which the 12-hour ibuprofen product will compete are estimated at more than $8 billion, according to IMS Review Plus data. The Company estimates the annual U.S. sales of immediate-release OTC ibuprofen products exceeds $1 billion.

Company representatives will be making a presentation including information from its recently completed trial and its stability data on May 6, 2008, at the Taglich Brothers 5^th Annual Small Cap Equity Conference at the Le Parker Meriden Hotel, New York.

About SCOLR Pharma:

Based in Bellevue, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma’s corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.373.0171 or visit http://www.scolr.com/.

This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products. And we may not obtain regulatory approval for our products, which would materially impair our ability to generate revenue. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances.

Contact:
Investor Relations:
Cameron Associates
Kevin McGrath, 212-245-4577
Kevin@cameronassoc.com

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Source: SCOLR Pharma, Inc.