Dr. Wright also stated that based on the recent study results, there are good reasons to consider bioequivalence testing of this class of product. Depending on results of this 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.
Rock Creek Pharmaceuticals has a central focus on the development and manufacturing of a low-cost NRT pharmaceutical cessation products. The company will continue to explore at the same time development of other pharmaceutical products with clinical claims, as well as a "relapse prevention product" to assist smokers during nicotine withdrawal. 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. Rock Creek is dedicated to developing an array of pharmaceutical and related products that promote the concept that "smoking is not an option."
Paul L. Perito, Rock Creek Pharmaceutical's Chairman and CEO, commented that Star Scientific is fortunate to have a respected medical and scientific professional like Dr. Wright, with extensive prior FDA and pharmaceutical company experience, to lead this vital drug development effort. Mr. Perito further noted that depending on results from the bioequivalence study, and parallel work that will be done by Rock Creek with a contract research organization or academic institution, the company expects to move forward with the FDA approval process as soon as practicable.
|SOURCE Star Scientific|
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