Clinical study of Prevora surpassed FDA's objectives for preventing adult
tooth decay

TORONTO, Aug. 25 /CNW/ - CHX Technologies Inc., a private Canadian pharmaceutical company that is developing new treatments for the prevention of dental diseases, today announced successful results in its final controlled pivotal trial of Prevora, its proprietary antibacterial tooth coating for the prevention of cavities. The trial surpassed objectives set by the Food and Drug Administration (FDA) protocol, clearing the way for CHX to start the process of seeking FDA approval for use in the United States.  In this study Prevora was shown to reduce cavities by 37% (p = 0.04) over one year in all participants, and most profoundly, by 60% (p=0.006) amongst participants at study sites with the most severe levels of decay. For this study the FDA set an objective of 20% reduction of cavities at p ≤ 0.05.   

Prevora is a proprietary topical coating developed by CHX which is applied to the teeth of the patient by the hygienist in a short, painless appointment. The active ingredient, chlorhexidine, is a well-known antiseptic used in both dentistry and medicine.  Prevora works by attacking the bacteria Streptococci mutans, which cause tooth decay.  

Tooth decay is the most common infection in adults, ranks as one of the most expensive diseases and is implicated as a significant contributor to overall health. The U.S. Center for Disease Control reports that 23% of American adults have untreated tooth decay.  

The Phase IIIB study of Prevora found that the worst tooth decay was amongst the uninsured and public health groups, which account for half of Americans today.  The number of uninsured Americans is growing quickly as baby boomers retire, as large employers change their benefit plans, and as working in small business or being self-employed becomes more common.  

"In this context, Prevora's profound prevention of tooth decay, especially for the uninsured, is timely and creates a new, painless and effective preventive service for the dental office to offer a changing market." said Ross Perry, President of CHX.  

About the Pivotal Study:  This study was a randomized, placebo-controlled, double-blinded prospective study conducted according to a protocol developed with the FDA. It involved 983 adults with mean age of 43 years. The study participants had at least one cavity upon screening, and were recruited so that they were representative of how Americans pay for their dental care. Six out of 10 participants had dental insurance, 4 in 10 were uninsured or received public health care. There was a significant range of cavities in the study participants, making the results generalisable to the American adult population. In this study, Prevora or its placebo was topically applied by the dental hygienist in five short appointments and observed over 13 months.  

About the prevention of cavities in adults:  Currently, there are no treatments for adult tooth decay which are proven in randomized controlled studies nor are there any approved preventive treatments to be used in the dental office specifically for adult cavities in the United States.  Prevora fills this need.  

About Prevora:  Prevora has successfully completed three randomized controlled studies in a spectrum of at-risk patients. Prevora is approved in Canada and Ireland as an in-office prescription preventive treatment for cavities at the gum line, the most common form of decay after age 60. CHX has submitted the results of this Phase IIIB study to European regulatory authorities for broader approvals of Prevora in the European Union, and intends to meet with the FDA to define a critical path for submission of a new drug application for Prevora in the U.S. Prevora has been available through dental offices in Canada since 2007.  

CHX is a leader in conducting randomized controlled clinical trials in preventive dental care and in developing effective consumer awareness campaigns to encourage the adoption of Prevora as a preventive treatment in family dental offices.   

See:  href="">http://www.chxtechnologies.com 


For further information: For further information:

Ross Perry, CHX Technologies
Tel: (416) 233-3737 or   

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