Star Scientific Corporate Study Stonewall Lozenge in NRT..

January 10, 2009 - Star Scientific (SS) is pursuing the development of a low-cost botanical-based Nicotine Replacement Product (NRT) for both smoking and smokeless tobacco cessation. Dr. Curtis Wright, Chief Medical Officer of Rock Creek Pharmaceuticals, Inc., a subsidiary of Star Scientific, stated that we have to move beyond the current situation that makes NRT more expensive than continuing to use tobacco. The goal is to achieve higher quit and long-term abstinence rates for dependent smokers for whom conventional NRT smoking
cessation products have not been successful.

SS announced today, January 6, 2009 that Rock Creek in junction with its Star Tobacco, Inc. subsidiary, recently completed a study to determine the ability of
Stonewall(R) dissolvable smokeless tobacco to relieve cigarette withdrawal symptoms when compared to an over-the-counter nicotine replacement product.
The study, which included 49 cigarette smokers, was designed to measure 1) nicotine's effects and 2) relief from smoking withdrawal symptoms, using a 4mg NRT product and a 4mg Stonewall piece, along with placebos of each product. The NRT, Stonewall product and the two placebos were administered over the course of four sessions. Both the nicotine replacement product and the 4mg Stonewall product were much more effective than their placebos in reducing nicotine craving, confirming the preliminary results published in 2007 in the journal Tobacco Control.

Depending on results of bioequivalence testing, Rock Creek plans to seek FDA review for a botanical-based tobacco cessation product for use by adult tobacco users who smoke and/or use smokeless tobacco products. The company anticipates using the name CigRX(TM) as the trade name. There currently is no FDA-approved pharmaceutical product for smokeless tobacco cessation.

Reference: Star Scientific Announces Successful Completion of Product Satisfaction Study..

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